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Regulatory
Every record is one authority's decision for one application or DIN, shown with its jurisdiction, date, indication text as published and status. A molecule approved in one jurisdiction for one indication is not 'approved' in general.
RegulatoryDevelopment pipeline →Methodology
Coverage
Counts of records, not of drugs approved: one application can carry several dated records (original approval, efficacy supplements, one row per DIN in Canada).
Approval records
4,342
Distinct drugs
373
Records naming a cancer
982
Dated in the last 12 months
179
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |
|---|---|---|---|---|---|---|---|
| FDA | US | 2,343 | 304 | 2,343 | 0 | 115 | Sep 18, 2026 |
| Health Canada | CA | 1,538 | 273 | 979 | 559 | 44 | Sep 22, 2026 |
| EMA | EU | 461 | 246 | 386 | 75 | 20 | Sep 18, 2026 |
Data updated 22 hours agoSource updated unknown3 authority · jurisdiction pairs ingested
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Latest approval date first; records without a date are listed last. Filters combine.
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1974 | Asparaginase | Health Canada CA | cancer not stated in this record | Marketed in Canada as KIDROLASE (DIN 01926438) under ATC L01XX02 ASPARAGINASE. Indications are not published in the Drug Product Database —… | DIN01926438 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 19, 1974 | Tretinoin | FDA US | cancer not stated in this record | Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this… | ORIGNDA017522 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1973 | Cyclophosphamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as PROCYTOX TAB 25MG (DIN 00262676) under ATC L01AA01 CYCLOPHOSPHAMIDE. Indications are not published in the Drug… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 10, 1973 | Prednisolone | FDA US | cancer not stated in this record | : Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 30, 1973 | Prednisolone | FDA US | cancer not stated in this record | PRED FORTE ® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and… | ORIGNDA017011 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 26, 1973 | Tretinoin | FDA US | cancer not stated in this record | Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this… | ORIGNDA017340 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 10, 1972 | Prednisolone | FDA US | cancer not stated in this record | PRED MILD ® is indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva,… | ORIGNDA017100 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 17, 1972 | Prednisone | FDA US | cancer not stated in this record | Prednisone tablets, USP are indicated in the following conditions: Endocrine Disorders Primary or secondary adrenocortical insufficiency… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1971 | Daunorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as CERUBIDINE (DIN 01926683) under ATC L01DB02 DAUNORUBICIN. Indications are not published in the Drug Product Database… | DIN01926683 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1970 | Procarbazine | Health Canada CA | cancer not stated in this record | Marketed in Canada as MATULANE (DIN 00012750) under ATC L01XB01 PROCARBAZINE. Indications are not published in the Drug Product Database —… | DIN00012750 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 29, 1970 | Fluorouracil | FDA US | cancer not stated in this record | Original approval 1970-07-29 — label text not available on openFDA | ORIGNDA016831 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 22, 1969 | Procarbazine | FDA US | Hodgkin Lymphoma | Matulane is indicated for use in combination with other anticancer drugs for the treatment of Stage III and IV Hodgkin's disease. Matulane… | ORIG |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 20, 1968 | Azathioprine | FDA US | cancer not stated in this record | : IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 7, 1967 | Hydroxyurea | FDA US | cancer not stated in this record | DROXIA is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1966 | Cyclophosphamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as PROCYTOX VIAL 1000MG (DIN 00013552) under ATC L01AA01 CYCLOPHOSPHAMIDE. Indications are not published in the Drug… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 18, 1966 | Thioguanine | FDA US | cancer not stated in this record | a) Acute Nonlymphocytic Leukemias TABLOID brand Thioguanine is indicated for remission induction and remission consolidation treatment of… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1964 | Melphalan | Health Canada CA | cancer not stated in this record | Marketed in Canada as ALKERAN (DIN 00004715) under ATC L01AA03 MELPHALAN. Indications are not published in the Drug Product Database — see… | DIN00004715 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1963 | Dactinomycin | Health Canada CA | cancer not stated in this record | Marketed in Canada as COSMEGEN (DIN 00213071) under ATC L01DA01 DACTINOMYCIN. Indications are not published in the Drug Product Database —… | DIN00213071 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 20, 1962 | Dexamethasone | FDA US | cancer not stated in this record | Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1959 | Thiotepa | Health Canada CA | cancer not stated in this record | Marketed in Canada as THIO TEPA INJ 15MG/VIAL (DIN 00237035) under ATC L01AC01 THIOTEPA. Indications are not published in the Drug Product… | DIN00237035 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 16, 1959 | Cyclophosphamide | FDA US | cancer not stated in this record | Malignant Diseases: malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 10, 1959 | Methotrexate | FDA US | cancer not stated in this record | o Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen. • Treatment of adults with… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1958 | Diethylstilbestrol | Health Canada CA | cancer not stated in this record | Marketed in Canada as HONVOL TABLETS 100MG (DIN 00013781) under ATC L02AA01 DIETHYLSTILBESTROL. Indications are not published in the Drug… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1957 | Chlorambucil | Health Canada CA | cancer not stated in this record | Marketed in Canada as LEUKERAN (DIN 00004626) under ATC L01AA02 CHLORAMBUCIL. Indications are not published in the Drug Product Database —… | DIN00004626 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 18, 1957 | Chlorambucil | FDA US | cancer not stated in this record | LEUKERAN (chlorambucil) is indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1956 | Diethylstilbestrol | Health Canada CA | cancer not stated in this record | Marketed in Canada as HONVOL AMPOULES 250MG (DIN 00013587) under ATC L02AA01 DIETHYLSTILBESTROL. Indications are not published in the Drug… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1955 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE TAB 2.5MG (DIN 00014915) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug… | DIN00014915 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 18, 1955 | Hydroxychloroquine | FDA US | cancer not stated in this record | Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale , and Plasmodium vivax in adult and… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1954 | Mercaptopurine | Health Canada CA | cancer not stated in this record | Marketed in Canada as PURINETHOL (DIN 00004723) under ATC L01BB02 MERCAPTOPURINE. Indications are not published in the Drug Product… | DIN00004723 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 26, 1954 | Busulfan | FDA US | Myeloid Leukemia | MYLERAN (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia. | ORIGNDA009386 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 11, 1953 | Mercaptopurine | FDA US | Acute Lymphoblastic Leukemia | 1 INDICATIONS & USAGE Mercaptopurine tablets is a nucleoside metabolic inhibitor indicated for treatment of adult and pediatric patients… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1951 | Mechlorethamine | Health Canada CA | cancer not stated in this record | Marketed in Canada as MUSTARGEN (DIN 00016063) under ATC L01AA05 CHLORMETHINE. Indications are not published in the Drug Product Database —… | DIN00016063 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| — | Isatuximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as SARCLISA SC (DIN 02571498) under ATC L01FC02 ISATUXIMAB. Indications are not published in the Drug Product Database —… | DIN02571498 |
A record is one authority's decision for one application/DIN; the same molecule appears once per jurisdiction and indication. Health Canada DPD does not publish indications — its records state the brand, DIN and ATC class only, and a cancelled or dormant DIN is the status of one product, not of the molecule. FDA cancer mappings come from label text and are flagged probabilistic on the drug page.
| withdrawnsource: Cancelled Post Marketsince Jul 7, 2021 |
| health-canada-dpd |
| Dec 31, 1974 | Thioguanine | Health Canada CA | cancer not stated in this record | Marketed in Canada as LANVIS (DIN 00282081) under ATC L01BB03 TIOGUANINE. Indications are not published in the Drug Product Database — see… | DIN00282081 | approvedsource: Marketed | health-canada-dpd |
| Dec 11, 1974 | Chloroquine | FDA US | cancer not stated in this record | Chloroquine phosphate tablets are indicated for the: Treatment of uncomplicated malaria due to susceptible strains of P. falciparum,… | ORIGANDA080880 | approved | openfda |
| approved |
| openfda |
| withdrawnsource: Cancelled Post Marketsince May 22, 2001 |
| health-canada-dpd |
| Dec 31, 1973 | Bleomycin | Health Canada CA | cancer not stated in this record | Marketed in Canada as BLENOXANE PWS 15UNIT (DIN 00258482) under ATC L01DC01 BLEOMYCIN. Indications are not published in the Drug Product… | DIN00258482 | withdrawnsource: Cancelled Post Marketsince Oct 19, 2011 | health-canada-dpd |
| ORIGNDA017469 |
| approved |
| openfda |
| openfda |
| approved |
| openfda |
| approved |
| openfda |
| ORIGANDA080356 |
| approved |
| openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Jul 8, 1970 | Mitotane | FDA US | Adrenal Cortical Carcinoma | LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). LYSODREN… | ORIGNDA016885 | approved | openfda |
| approved |
| openfda |
| ORIGNDA016324 |
| approved |
| openfda |
| ORIGNDA016295 |
| approved |
| openfda |
| withdrawnsource: Cancelled Post Marketsince May 22, 2001 |
| health-canada-dpd |
| ORIGNDA012429 |
| approved |
| openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| ORIGNDA013422 |
| approved |
| openfda |
| withdrawnsource: Cancelled Post Marketsince Nov 24, 1997 |
| health-canada-dpd |
| Dec 31, 1959 | Cyclophosphamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as PROCYTOX VIAL 200MG (DIN 00013544) under ATC L01AA01 CYCLOPHOSPHAMIDE. Indications are not published in the Drug… | DIN00013544 | withdrawnsource: Cancelled Post Marketsince Nov 26, 2000 | health-canada-dpd |
| Dec 31, 1959 | Cyclophosphamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as PROCYTOX TABLETS 50MG (DIN 00013749) under ATC L01AA01 CYCLOPHOSPHAMIDE. Indications are not published in the Drug… | DIN00013749 | withdrawnsource: Cancelled Post Marketsince May 22, 2001 | health-canada-dpd |
| ORIGNDA012141 |
| approved |
| openfda |
| ORIGNDA011719 |
| approved |
| openfda |
| Aug 10, 1959 | Methotrexate | FDA US | Head and Neck Squamous Cell Carcinoma | o Treatment of adults with squamous cell carcinoma of the head and neck as a single agent. | ORIGNDA011719 | approved | openfda |
| Aug 10, 1959 | Methotrexate | FDA US | Malignant Breast Neoplasm | o Treatment of adults with breast cancer as part of a combination chemotherapy regimen. | ORIGNDA011719 | approved | openfda |
| Aug 10, 1959 | Methotrexate | FDA US | Osteosarcoma | o Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. | ORIGNDA011719 | approved | openfda |
| Aug 10, 1959 | Methotrexate | FDA US | Non-Hodgkin Lymphoma | o Treatment of adult and pediatric patients with non-Hodgkin lymphoma. | ORIGNDA011719 | approved | openfda |
| Aug 10, 1959 | Methotrexate | FDA US | Meningeal Leukemia | o Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia. | ORIGNDA011719 | approved | openfda |
| Aug 10, 1959 | Methotrexate | FDA US | Acute Lymphoblastic Leukemia | The following neoplastic diseases for the: o Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a… | ORIGNDA011719 | approved | openfda |
| withdrawnsource: Cancelled Post Marketsince May 22, 2001 |
| health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| ORIGNDA010669 |
| approved |
| openfda |
| withdrawnsource: Cancelled Post Marketsince Nov 17, 2000 |
| health-canada-dpd |
| withdrawnsource: Cancelled Post Marketsince Aug 14, 1997 |
| health-canada-dpd |
| ORIGNDA009768 |
| approved |
| openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| Dec 31, 1954 | Busulfan | Health Canada CA | cancer not stated in this record | Marketed in Canada as MYLERAN (DIN 00004618) under ATC L01AB01 BUSULFAN. Indications are not published in the Drug Product Database — see… | DIN00004618 | approvedsource: Marketed | health-canada-dpd |
| openfda |
| ORIGNDA009053 |
| approved |
| openfda |
| withdrawnsource: Cancelled Post Marketsince Nov 11, 2011 |
| health-canada-dpd |
| approved |
| health-canada-dpd |
| — | Abiraterone Acetate | Health Canada CA | cancer not stated in this record | Marketed in Canada as MINT-ABIRATERONE (DIN 02571447) under ATC L02BX03 ABIRATERONE. Indications are not published in the Drug Product… | DIN02571447 | approved | health-canada-dpd |
| — | Abiraterone Acetate | Health Canada CA | cancer not stated in this record | Marketed in Canada as MINT-ABIRATERONE (DIN 02571439) under ATC L02BX03 ABIRATERONE. Indications are not published in the Drug Product… | DIN02571439 | approved | health-canada-dpd |
| — | Enzalutamide | EMA EU | Malignant Prostate Neoplasm | Treatment of prostate cancer. | centralisedEMEA/H/C/006612 | approved | ema |