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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 yesterdaySource 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 2, 1996 | Mitoxantrone | Health Canada CA | cancer not stated in this record | Marketed in Canada as NOVANTRONE (DIN 02173468) under ATC L01DB07 MITOXANTRONE. Indications are not published in the Drug Product Database… | DIN02173468 | withdrawnsource: Cancelled Post Marketsince Aug 10, 2005 | health-canada-dpd |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 18, 1996 | Raltitrexed | Health Canada CA | cancer not stated in this record | Marketed in Canada as TOMUDEX (DIN 02229566) under ATC L01BA03 RALTITREXED. Indications are not published in the Drug Product Database —… | DIN02229566 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 25, 1996 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 1996-10-25 (see label) | SUPPLNDA019839 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 23, 1996 | Carmustine | FDA US | cancer not stated in this record | GLIADEL Wafer is indicated for the treatment of patients with: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation,… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 30, 1996 | Anastrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as ARIMIDEX (DIN 02224135) under ATC L02BG03 ANASTROZOLE. Indications are not published in the Drug Product Database —… | DIN02224135 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 30, 1996 | Diethylstilbestrol | Health Canada CA | cancer not stated in this record | Marketed in Canada as STILBESTROL TABLETS 0.1 MG (DIN 02091488) under ATC L02AA01 DIETHYLSTILBESTROL. Indications are not published in the… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 27, 1996 | Ibuprofen | FDA US | cancer not stated in this record | USES temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches | ORIGNDA020589 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 28, 1996 | Topotecan | FDA US | Malignant Cervical Neoplasm | Patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with… | ORIGNDA020671 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 14, 1996 | Toremifene | EMA EU | Malignant Breast Neoplasm | First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.Fareston is not recommended for… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 11, 1996 | Goserelin | FDA US | Prostate Carcinoma | Use as palliative treatment of advanced carcinoma of the prostate | ORIGNDA020578 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1995 | Megestrol | Health Canada CA | cancer not stated in this record | Marketed in Canada as MEGESTROL (DIN 02195917) under ATC L02AB01 MEGESTROL. Indications are not published in the Drug Product Database —… | DIN02195917 |
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.
| approvedsource: Marketed |
| health-canada-dpd |
| Nov 15, 1996 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as PMS-METHOTREXATE (DIN 02170698) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product… | DIN02170698 | approvedsource: Marketed | health-canada-dpd |
| Nov 12, 1996 | Topotecan | EMA EU | cancer not stated in this record | Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom… | centralisedEMEA/H/C/000123 | approved | ema |
| Oct 10, 1996 | Dacarbazine | Health Canada CA | cancer not stated in this record | Marketed in Canada as DTIC-DOME -PWS IV 200MG/VIAL (DIN 02154854) under ATC L01AX04 DACARBAZINE. Indications are not published in the Drug… | DIN02154854 | withdrawnsource: Cancelled Post Marketsince May 31, 2005 | health-canada-dpd |
| ORIGNDA020637 |
| approved |
| openfda |
| Sep 23, 1996 | Cytarabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as CYTARABINE INJECTION (DIN 02126656) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product… | DIN02126656 | approvedsource: Marketed | health-canada-dpd |
| Sep 5, 1996 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE SODIUM INJECTION USP (DIN 02161168) under ATC L01BA01 METHOTREXATE. Indications are not published in the… | DIN02161168 | withdrawnsource: Cancelled Post Marketsince Aug 2, 2006 | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Aug 28, 1996 | Goserelin | Health Canada CA | cancer not stated in this record | Marketed in Canada as ZOLADEX LA (DIN 02225905) under ATC L02AE03 GOSERELIN. Indications are not published in the Drug Product Database —… | DIN02225905 | approvedsource: Marketed | health-canada-dpd |
| withdrawnsource: Cancelled Post Marketsince Feb 23, 2009 |
| health-canada-dpd |
| Jul 30, 1996 | Diethylstilbestrol | Health Canada CA | cancer not stated in this record | Marketed in Canada as STILBESTROL TABLETS 1.0 MG (DIN 02091461) under ATC L02AA01 DIETHYLSTILBESTROL. Indications are not published in the… | DIN02091461 | withdrawnsource: Cancelled Post Marketsince Feb 23, 2009 | health-canada-dpd |
| openfda |
| Jun 25, 1996 | Ibandronic Acid | EMA EU | cancer not stated in this record | Treatment of tumour-induced hypercalcaemia with or without metastases. | centralisedEMEA/H/C/000103 | withdrawn | ema |
| Jun 25, 1996 | Ibandronic Acid | EMA EU | cancer not stated in this record | Bondronat is indicated for: prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in… | centralisedEMEA/H/C/000101 | approved | ema |
| Jun 20, 1996 | Doxorubicin | EMA EU | cancer not stated in this record | Caelyx pegylated liposomal is indicated: as monotherapy for patients with metastatic breast cancer, where there is an increased… | centralisedEMEA/H/C/000089 | approved | ema |
| Jun 14, 1996 | Irinotecan | FDA US | Colon Carcinoma | Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based… | ORIGNDA020571 | approved | openfda |
| Jun 14, 1996 | Irinotecan | FDA US | Colon Carcinoma | First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. ( 1 ) | ORIGNDA020571 | approved | openfda |
| Jun 14, 1996 | Irinotecan | FDA US | Colon Carcinoma | CAMPTOSAR is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following… | ORIGNDA020571 | approved | openfda |
| Jun 14, 1996 | Irinotecan | FDA US | Colon Carcinoma | CAMPTOSAR is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with… | ORIGNDA020571 | approved | openfda |
| Jun 10, 1996 | Ibuprofen | FDA US | cancer not stated in this record | Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches | ORIGNDA020603 | approved | openfda |
| openfda |
| May 28, 1996 | Topotecan | FDA US | Lung Small Cell Carcinoma | Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line… | ORIGNDA020671 | approved | openfda |
| May 28, 1996 | Topotecan | FDA US | Malignant Ovarian Neoplasm | Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent | ORIGNDA020671 | approved | openfda |
| May 17, 1996 | Interferon Beta-1a | FDA US | cancer not stated in this record | AVONEX is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome,… | ORIGBLA103628 | approved | openfda |
| May 17, 1996 | Etoposide | FDA US | cancer not stated in this record | Refractory testicular tumors, in combination with other chemotherapeutic drugs. | ORIGNDA020457 | approved | openfda |
| May 17, 1996 | Etoposide | FDA US | Lung Small Cell Carcinoma | Small cell lung cancer, in combination with cisplatin, as first-line treatment. | ORIGNDA020457 | approved | openfda |
| May 14, 1996 | Docetaxel | FDA US | Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of the Head and Neck (SCCHN) : with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN | ORIGNDA020449 | approved | openfda |
| May 14, 1996 | Docetaxel | FDA US | Gastric Adenocarcinoma | Gastric Adenocarcinoma (GC) : with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction | ORIGNDA020449 | approved | openfda |
| May 14, 1996 | Docetaxel | FDA US | Castration-Resistant Prostate Carcinoma | Castration-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate cancer | ORIGNDA020449 | approved | openfda |
| May 14, 1996 | Docetaxel | FDA US | Lung Non-Small Cell Carcinoma | Non-small Cell Lung Cancer (NSCLC) : single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with… | ORIGNDA020449 | approved | openfda |
| May 14, 1996 | Docetaxel | FDA US | Malignant Breast Neoplasm | Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and… | ORIGNDA020449 | approved | openfda |
| centralisedEMEA/H/C/000091 |
| approved |
| ema |
| Jan 11, 1996 | Goserelin | FDA US | Prostate Carcinoma | Use in combination with flutamide for the management of locally confined carcinoma of the prostate | ORIGNDA020578 | approved | openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| Dec 31, 1995 | Megestrol | Health Canada CA | cancer not stated in this record | Marketed in Canada as MEGESTROL (DIN 02195925) under ATC L02AB01 MEGESTROL. Indications are not published in the Drug Product Database —… | DIN02195925 | approvedsource: Marketed | health-canada-dpd |
| Dec 31, 1995 | Bacillus Calmette-Guerin (bcg) Strain Tice | Health Canada CA | cancer not stated in this record | Marketed in Canada as ONCOTICE (DIN 02153513) under ATC L03AX03 BCG VACCINE. Indications are not published in the Drug Product Database —… | DIN02153513 | approvedsource: Marketed | health-canada-dpd |
| Dec 31, 1995 | Vincristine | Health Canada CA | cancer not stated in this record | Marketed in Canada as VINCRISTINE SULFATE INJECTION (DIN 02143305) under ATC L01CA02 VINCRISTINE. Indications are not published in the Drug… | DIN02143305 | approvedsource: Marketed | health-canada-dpd |
| Dec 31, 1995 | Porfimer | Health Canada CA | cancer not stated in this record | Marketed in Canada as PHOTOFRIN (DIN 02020033) under ATC L01XD01 PORFIMER SODIUM. Indications are not published in the Drug Product… | DIN02020033 | withdrawnsource: Cancelled Post Marketsince Nov 21, 2014 | health-canada-dpd |
| Dec 31, 1995 | Porfimer | Health Canada CA | cancer not stated in this record | Marketed in Canada as PHOTOFRIN (DIN 02019876) under ATC L01XD01 PORFIMER SODIUM. Indications are not published in the Drug Product… | DIN02019876 | withdrawnsource: Cancelled Post Marketsince Jul 18, 2019 | health-canada-dpd |
| Dec 31, 1995 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE SODIUM INJECTION (DIN 02099705) under ATC L01BA01 METHOTREXATE. Indications are not published in the… | DIN02099705 | approvedsource: Marketed | health-canada-dpd |
| Dec 31, 1995 | Cytarabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as CYTARABINE - PWS 2GM/VIAL (DIN 02167891) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug… | DIN02167891 | withdrawnsource: Cancelled Post Marketsince Oct 26, 2015 | health-canada-dpd |
| Dec 31, 1995 | Cytarabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as CYTARABINE - PWS 1GN/VIAL (DIN 02167883) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug… | DIN02167883 | withdrawnsource: Cancelled Post Marketsince Oct 26, 2015 | health-canada-dpd |
| Dec 31, 1995 | Cytarabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as CYTARABINE-PWS 100MG/VIAL (DIN 02167867) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug… | DIN02167867 | withdrawnsource: Cancelled Post Marketsince May 7, 2018 | health-canada-dpd |
| Dec 31, 1995 | Cytarabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as CYTARABINE - PWS 500MG/VIAL (DIN 02167875) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug… | DIN02167875 | withdrawnsource: Cancelled Post Marketsince Oct 26, 2015 | health-canada-dpd |
| Dec 31, 1995 | Estramustine | Health Canada CA | cancer not stated in this record | Marketed in Canada as EMCYT (DIN 02063794) under ATC L01XX11 ESTRAMUSTINE. Indications are not published in the Drug Product Database — see… | DIN02063794 | withdrawnsource: Cancelled Post Marketsince Apr 30, 2020 | health-canada-dpd |
| Dec 31, 1995 | Megestrol | Health Canada CA | cancer not stated in this record | Marketed in Canada as LINMEGESTROL - TAB 160MG (DIN 02176106) under ATC L02AB01 MEGESTROL. Indications are not published in the Drug… | DIN02176106 | withdrawnsource: Cancelled Post Marketsince May 29, 2006 | health-canada-dpd |
| Dec 31, 1995 | Megestrol | Health Canada CA | cancer not stated in this record | Marketed in Canada as LINMEGESTROL - TAB 40MG (DIN 02176092) under ATC L02AB01 MEGESTROL. Indications are not published in the Drug Product… | DIN02176092 | withdrawnsource: Cancelled Post Marketsince Aug 5, 2004 | health-canada-dpd |