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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 2 days 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 |
|---|---|---|---|---|---|---|---|
| Oct 26, 2000 | Cyclophosphamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as PROCYTOX (DIN 02241798) under ATC L01AA01 CYCLOPHOSPHAMIDE. Indications are not published in the Drug Product… | DIN02241798 | approvedsource: Marketed | health-canada-dpd |
| Oct 11, 2000 | Alitretinoin | EMA EU | AIDS-Related Kaposi Sarcoma | Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with acquired-immune-deficiency-syndrome… | centralisedEMEA/H/C/000279 | withdrawn | ema |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 25, 2000 | Arsenic Trioxide | FDA US | cancer not stated in this record | For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 31, 2000 | Tretinoin | FDA US | cancer not stated in this record | (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) RENOVA… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 13, 2000 | Doxorubicin | EMA EU | Malignant Breast Neoplasm | Myocet liposomal, in combination with cyclophosphamide, is indicated for the first-line treatment of metastatic breast cancer in adult… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 28, 2000 | Bexarotene | FDA US | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Targretin (bexarotene) gel 1% is indicated for the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 20, 2000 | Irinotecan | FDA US | cancer not stated in this record | Efficacy supplement 2000-04-20 (see label) | SUPPLNDA020571 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 20, 2000 | Rituximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as RITUXAN (DIN 02241927) under ATC L01FA01 RITUXIMAB. Indications are not published in the Drug Product Database — see… | DIN02241927 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 24, 2000 | Buserelin | Health Canada CA | cancer not stated in this record | Marketed in Canada as SUPREFACT DEPOT 3 MONTHS (DIN 02240749) under ATC L02AE01 BUSERELIN. Indications are not published in the Drug… | DIN02240749 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 29, 1999 | Bexarotene | FDA US | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | TARGRETIN ® (bexarotene) Capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 12, 1999 | Temozolomide | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEMODAL (DIN 02241096) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database —… | DIN02241096 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 21, 1999 | Exemestane | FDA US | Malignant Breast Neoplasm | treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2 ). | ORIGNDA020753 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 28, 1999 | Tamoxifen | Health Canada CA | cancer not stated in this record | Marketed in Canada as TAMOXIFEN (DIN 02237597) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database —… | DIN02237597 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 23, 1999 | Trastuzumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as HERCEPTIN (DIN 02240692) under ATC L01FD01 TRASTUZUMAB. Indications are not published in the Drug Product Database —… | DIN02240692 |
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.
| ORIGNDA021248 |
| approved |
| openfda |
| Sep 25, 2000 | Arsenic Trioxide | FDA US | Acute Promyelocytic Leukemia | In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is… | ORIGNDA021248 | approved | openfda |
| Sep 1, 2000 | Anastrozole | FDA US | cancer not stated in this record | Efficacy supplement 2000-09-01 (see label) | SUPPLNDA020541 | approved | openfda |
| Sep 1, 2000 | Cyclophosphamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as PROCYTOX (DIN 02241795) under ATC L01AA01 CYCLOPHOSPHAMIDE. Indications are not published in the Drug Product… | DIN02241795 | approvedsource: Marketed | health-canada-dpd |
| ORIGNDA021108 |
| approved |
| openfda |
| Aug 31, 2000 | Tretinoin | FDA US | Malignant Skin Neoplasm | Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin… | ORIGNDA021108 | approved | openfda |
| Aug 28, 2000 | Trastuzumab | EMA EU | cancer not stated in this record | Breast cancer Metastatic breast cancer Herceptin is indicated for the treatment of patients with HER2-positive metastatic breast cancer: as… | centralisedEMEA/H/C/000278 | approved | ema |
| Aug 25, 2000 | Sirolimus | FDA US | cancer not stated in this record | - Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended… | ORIGNDA021110 | approved | openfda |
| Aug 22, 2000 | Cyclophosphamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as PROCYTOX (DIN 02241796) under ATC L01AA01 CYCLOPHOSPHAMIDE. Indications are not published in the Drug Product… | DIN02241796 | approvedsource: Marketed | health-canada-dpd |
| Aug 17, 2000 | Exemestane | Health Canada CA | cancer not stated in this record | Marketed in Canada as AROMASIN (DIN 02242705) under ATC L02BG06 EXEMESTANE. Indications are not published in the Drug Product Database —… | DIN02242705 | approvedsource: Marketed | health-canada-dpd |
| centralisedEMEA/H/C/000297 |
| approved |
| ema |
| ORIGNDA021056 |
| approved |
| openfda |
| Jun 15, 2000 | Triptorelin | FDA US | Malignant Prostate Neoplasm | TRELSTAR is indicated for the treatment of advanced prostate cancer [ see Clinical Studies (14) ]. TRELSTAR is a gonadotropin releasing… | ORIGNDA020715 | approved | openfda |
| Apr 12, 2000 | Verteporfin | FDA US | cancer not stated in this record | VISUDYNE ® (verteporfin for injection) therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal… | ORIGNDA021119 | approved | openfda |
| Apr 4, 2000 | Dacarbazine | Health Canada CA | cancer not stated in this record | Marketed in Canada as DACARBAZINE FOR INJECTION BP (DIN 02241445) under ATC L01AX04 DACARBAZINE. Indications are not published in the Drug… | DIN02241445 | approvedsource: Marketed | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Mar 10, 2000 | Bleomycin | FDA US | cancer not stated in this record | Bleomycin for Injection should be considered a palliative treatment. It has been shown to be useful in the management of the following… | ORIGANDA065031 | approved | openfda |
| Mar 9, 2000 | Interferon Alfa-2b | EMA EU | cancer not stated in this record | Chronic hepatitis B Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis-B viral replication… | centralisedEMEA/H/C/000281 | withdrawn | ema |
| Mar 9, 2000 | Thyrotropin Alfa | EMA EU | Differentiated Thyroid Gland Carcinoma | Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid… | centralisedEMEA/H/C/000220 | approved | ema |
| withdrawnsource: Dormantsince Oct 13, 2024 |
| health-canada-dpd |
| ORIGNDA021055 |
| approved |
| openfda |
| Dec 28, 1999 | Etoposide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ETOPOSIDE INJECTION, USP (DIN 02241182) under ATC L01CB01 ETOPOSIDE. Indications are not published in the Drug… | DIN02241182 | withdrawnsource: Cancelled Post Marketsince Jan 17, 2019 | health-canada-dpd |
| Dec 23, 1999 | Interferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as REBETRON SOLUTION (ALBUMIN (HUMAN) FREE) (18 MIU MULTI-DOSE PEN / 200MG CAPSULES) (DIN 02241159) under ATC L03AB60… | DIN02241159 | withdrawnsource: Cancelled Post Marketsince Oct 27, 2004 | health-canada-dpd |
| Dec 23, 1999 | Docetaxel | FDA US | cancer not stated in this record | Efficacy supplement 1999-12-23 (see label) | SUPPLNDA020449 | approved | openfda |
| Dec 7, 1999 | Sertraline | FDA US | cancer not stated in this record | Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social… | ORIGNDA020990 | approved | openfda |
| Dec 7, 1999 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 1999-12-07 (see label) | SUPPLNDA019839 | approved | openfda |
| Dec 3, 1999 | Aminolevulinic Acid | FDA US | cancer not stated in this record | The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is… | ORIGNDA020965 | approved | openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| Nov 12, 1999 | Temozolomide | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEMODAL (DIN 02241095) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database —… | DIN02241095 | approvedsource: Marketed | health-canada-dpd |
| Nov 12, 1999 | Temozolomide | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEMODAL (DIN 02241094) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database —… | DIN02241094 | approvedsource: Marketed | health-canada-dpd |
| Nov 12, 1999 | Temozolomide | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEMODAL (DIN 02241093) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database —… | DIN02241093 | approvedsource: Marketed | health-canada-dpd |
| openfda |
| Oct 21, 1999 | Exemestane | FDA US | Malignant Breast Neoplasm | adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of… | ORIGNDA020753 | approved | openfda |
| withdrawnsource: Cancelled Post Marketsince Oct 25, 2016 |
| health-canada-dpd |
| Sep 28, 1999 | Tamoxifen | Health Canada CA | cancer not stated in this record | Marketed in Canada as TAMOXIFEN (DIN 02237596) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database —… | DIN02237596 | withdrawnsource: Cancelled Post Marketsince Oct 25, 2016 | health-canada-dpd |
| Sep 23, 1999 | Interferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as INTRON A (DIN 02240695) under ATC L03AB05 INTERFERON ALFA-2B. Indications are not published in the Drug Product… | DIN02240695 | withdrawnsource: Cancelled Post Marketsince Dec 14, 2018 | health-canada-dpd |
| Sep 23, 1999 | Interferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as INTRON A (DIN 02240694) under ATC L03AB05 INTERFERON ALFA-2B. Indications are not published in the Drug Product… | DIN02240694 | withdrawnsource: Cancelled Post Marketsince Feb 20, 2019 | health-canada-dpd |
| Sep 23, 1999 | Interferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as INTRON A (DIN 02240693) under ATC L03AB05 INTERFERON ALFA-2B. Indications are not published in the Drug Product… | DIN02240693 | withdrawnsource: Cancelled Post Marketsince Dec 20, 2018 | health-canada-dpd |
| Sep 23, 1999 | Busulfan | Health Canada CA | cancer not stated in this record | Marketed in Canada as BUSULFEX (DIN 02240602) under ATC L01AB01 BUSULFAN. Indications are not published in the Drug Product Database — see… | DIN02240602 | withdrawnsource: Cancelled Post Marketsince Sep 1, 2020 | health-canada-dpd |
| Sep 17, 1999 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-METHOTREXATE (DIN 02182963) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product… | DIN02182963 | approvedsource: Marketed | health-canada-dpd |
| Sep 15, 1999 | Sirolimus | FDA US | cancer not stated in this record | Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4… | ORIGNDA021083 | approved | openfda |
| Sep 15, 1999 | Epirubicin | FDA US | Malignant Breast Neoplasm | ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of… | ORIGNDA050778 | approved | openfda |
| Sep 13, 1999 | Leuprolide | Health Canada CA | cancer not stated in this record | Marketed in Canada as LUPRON DEPOT (DIN 02239834) under ATC L02AE02 LEUPRORELIN. Indications are not published in the Drug Product Database… | DIN02239834 | approvedsource: Marketed | health-canada-dpd |
| Sep 13, 1999 | Leuprolide | Health Canada CA | cancer not stated in this record | Marketed in Canada as LUPRON DEPOT (DIN 02239833) under ATC L02AE02 LEUPRORELIN. Indications are not published in the Drug Product Database… | DIN02239833 | approvedsource: Marketed | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Aug 11, 1999 | Temozolomide | FDA US | Anaplastic Astrocytoma | Treatment of adults with refractory anaplastic astrocytoma. | ORIGNDA021029 | approved | openfda |