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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 31, 1995 | Idarubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as IDAMYCIN POWDER -5MG/VIAL (DIN 02065630) under ATC L01DB06 IDARUBICIN. Indications are not published in the Drug… | DIN02065630 | withdrawnsource: Cancelled Post Marketsince Mar 21, 2014 | health-canada-dpd |
| Dec 31, 1995 | Idarubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as IDAMYCIN POWDER -10MG/VIAL (DIN 02068095) under ATC L01DB06 IDARUBICIN. Indications are not published in the Drug… | DIN02068095 | withdrawnsource: Cancelled Post Marketsince Mar 21, 2014 | health-canada-dpd |
| Dec 31, 1995 | Doxorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as ADRIAMYCIN RDF (DIN 02069555) under ATC L01DB01 DOXORUBICIN. Indications are not published in the Drug Product… | DIN02069555 | withdrawnsource: Cancelled Post Marketsince Aug 2, 2006 | health-canada-dpd |
| Dec 31, 1995 | Epirubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as PHARMORUBICIN RDF (DIN 02069512) under ATC L01DB03 EPIRUBICIN. Indications are not published in the Drug Product… | DIN02069512 | withdrawnsource: Cancelled Post Marketsince Aug 2, 2006 | health-canada-dpd |
| Dec 31, 1995 | Interferon Beta-1b | Health Canada CA | cancer not stated in this record | Marketed in Canada as BETASERON (DIN 02169649) under ATC L03AB08 INTERFERON BETA-1B. Indications are not published in the Drug Product… | DIN02169649 | approvedsource: Marketed | health-canada-dpd |
| Dec 31, 1995 | Megestrol | Health Canada CA | cancer not stated in this record | Marketed in Canada as MEGACE OS (DIN 02168979) under ATC L02AB01 MEGESTROL. Indications are not published in the Drug Product Database —… | DIN02168979 | withdrawnsource: Cancelled Post Marketsince Oct 20, 2017 | health-canada-dpd |
| Dec 31, 1995 | Fluorouracil | Health Canada CA | cancer not stated in this record | Marketed in Canada as ADRUCIL (DIN 02063921) under ATC L01BC02 FLUOROURACIL. Indications are not published in the Drug Product Database —… | DIN02063921 | withdrawnsource: Cancelled Post Marketsince Apr 8, 2004 | health-canada-dpd |
| Dec 31, 1995 | Docetaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as TAXOTERE (DIN 02177080) under ATC L01CD02 DOCETAXEL. Indications are not published in the Drug Product Database — see… | DIN02177080 | withdrawnsource: Cancelled Post Marketsince Jul 31, 2020 | health-canada-dpd |
| Dec 31, 1995 | Docetaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as TAXOTERE (DIN 02177099) under ATC L01CD02 DOCETAXEL. Indications are not published in the Drug Product Database — see… | DIN02177099 | withdrawnsource: Cancelled Post Marketsince Apr 30, 2018 | health-canada-dpd |
| Dec 31, 1995 | Epirubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as PHARMORUBICIN RDF (DIN 02065746) under ATC L01DB03 EPIRUBICIN. Indications are not published in the Drug Product… | DIN02065746 | withdrawnsource: Cancelled Post Marketsince Aug 2, 2006 | health-canada-dpd |
| Dec 31, 1995 | Melphalan | Health Canada CA | cancer not stated in this record | Marketed in Canada as ALKERAN (DIN 02087286) under ATC L01AA03 MELPHALAN. Indications are not published in the Drug Product Database — see… | DIN02087286 | approvedsource: Marketed | health-canada-dpd |
| Dec 31, 1995 | Doxorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as DOXORUBICIN HCL FOR INJ. U.S.P. 10MG/VIAL (DIN 02093057) under ATC L01DB01 DOXORUBICIN. Indications are not published… | DIN02093057 | withdrawnsource: Cancelled Post Marketsince Aug 13, 1998 | health-canada-dpd |
| Dec 31, 1995 | Doxorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as DOXORUBICIN HCL FOR INJ. U.S.P. 50MG/VIAL (DIN 02093073) under ATC L01DB01 DOXORUBICIN. Indications are not published… | DIN02093073 | withdrawnsource: Cancelled Post Marketsince Aug 14, 1997 | health-canada-dpd |
| Dec 31, 1995 | Doxorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as DOXORUBICIN HCL FOR INJ. U.S.P. 150MG/VIAL (DIN 02093081) under ATC L01DB01 DOXORUBICIN. Indications are not… | DIN02093081 | withdrawnsource: Cancelled Post Marketsince Aug 14, 1997 | health-canada-dpd |
| Dec 31, 1995 | Doxorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as ADRIAMYCIN PFS (DIN 02071002) under ATC L01DB01 DOXORUBICIN. Indications are not published in the Drug Product… | DIN02071002 | withdrawnsource: Dormantsince Aug 2, 2017 | health-canada-dpd |
| Dec 31, 1995 | Altretamine | Health Canada CA | cancer not stated in this record | Marketed in Canada as HEXALEN (DIN 02126230) under ATC L01XX03 ALTRETAMINE. Indications are not published in the Drug Product Database —… | DIN02126230 | withdrawnsource: Cancelled Post Marketsince Sep 9, 2013 | health-canada-dpd |
| Dec 31, 1995 | Tamoxifen | Health Canada CA | cancer not stated in this record | Marketed in Canada as NOLVADEX-D TAB 20MG (DIN 02048485) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product… | DIN02048485 | withdrawnsource: Cancelled Post Marketsince Mar 22, 2023 | health-canada-dpd |
| Dec 31, 1995 | Epirubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as PHARMORUBICIN PFS (DIN 02065703) under ATC L01DB03 EPIRUBICIN. Indications are not published in the Drug Product… | DIN02065703 | withdrawnsource: Cancelled Post Marketsince Jul 4, 2025 | health-canada-dpd |
| Dec 31, 1995 | Aldesleukin | Health Canada CA | cancer not stated in this record | Marketed in Canada as PROLEUKIN (DIN 02130181) under ATC L03AC01 ALDESLEUKIN. Indications are not published in the Drug Product Database —… | DIN02130181 | approvedsource: Marketed | health-canada-dpd |
| Dec 31, 1995 | Tretinoin | Health Canada CA | cancer not stated in this record | Marketed in Canada as VESANOID (DIN 02145839) under ATC L01XF01 TRETINOIN. Indications are not published in the Drug Product Database — see… | DIN02145839 | approvedsource: Marketed | health-canada-dpd |
| Dec 28, 1995 | Filgrastim | FDA US | cancer not stated in this record | Efficacy supplement 1995-12-28 (see label) | SUPPLBLA103353 | approved | openfda |
| Dec 27, 1995 | Anastrozole | FDA US | Malignant Breast Neoplasm | Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative… | ORIGNDA020541 | approved | openfda |
| Dec 27, 1995 | Anastrozole | FDA US | Malignant Breast Neoplasm | First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic… | ORIGNDA020541 | approved | openfda |
| Dec 27, 1995 | Anastrozole | FDA US | Malignant Breast Neoplasm | Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer | ORIGNDA020541 | approved | openfda |
| Dec 27, 1995 | Porfimer | FDA US | cancer not stated in this record | Ablation of high-grade dysplasia (HGD) in Barrett’s esophagus (BE) patients who do not undergo esophagectomy | ORIGNDA020451 | approved | openfda |
| Dec 27, 1995 | Porfimer | FDA US | Lung Non-Small Cell Carcinoma | Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated… | ORIGNDA020451 | approved | openfda |
| Dec 27, 1995 | Porfimer | FDA US | Malignant Esophageal Neoplasm | Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in… | ORIGNDA020451 | approved | openfda |
| Dec 27, 1995 | Porfimer | FDA US | Malignant Esophageal Neoplasm | Esophageal Cancer | ORIGNDA020451 | approved | openfda |
| Dec 22, 1995 | Leuprolide | FDA US | Malignant Prostate Neoplasm | LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month… | ORIGNDA020517 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 27, 1995 | Docetaxel | EMA EU | cancer not stated in this record | Breast cancer Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 4, 1995 | Bicalutamide | FDA US | Prostate Carcinoma | 1. INDICATIONS AND USAGE Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 29, 1995 | Prednisolone | FDA US | cancer not stated in this record | Efficacy supplement 1995-08-29 (see label) | SUPPLNDA017469 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 16, 1995 | Ibuprofen | FDA US | cancer not stated in this record | Uses temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever | ORIGNDA020516 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1994 | Cyclophosphamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as PROCYTOX FOR INJECTION 2000MG PWS IV (DIN 02094428) under ATC L01AA01 CYCLOPHOSPHAMIDE. Indications are not published… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 15, 1994 | Vinblastine | Health Canada CA | cancer not stated in this record | Marketed in Canada as VELBE 1MG/ML (DIN 00015431) under ATC L01CA01 VINBLASTINE. Indications are not published in the Drug Product Database… | DIN00015431 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 15, 1994 | Filgrastim | FDA US | cancer not stated in this record | Efficacy supplement 1994-06-15 (see label) | SUPPLBLA103353 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 1, 1994 | Pegaspargase | FDA US | Acute Lymphoblastic Leukemia | Acute lymphoblastic leukemia and hypersensitivity to asparaginase | ORIGBLA103411 | approved | openfda |
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.
| centralisedEMEA/H/C/000073 |
| approved |
| ema |
| Nov 17, 1995 | Doxorubicin | FDA US | Multiple Myeloma | Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one… | ORIGNDA050718 | approved | openfda |
| Nov 17, 1995 | Doxorubicin | FDA US | AIDS-Related Kaposi Sarcoma | AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy | ORIGNDA050718 | approved | openfda |
| Nov 17, 1995 | Doxorubicin | FDA US | Malignant Ovarian Neoplasm | Ovarian cancer: After failure of platinum-based chemotherapy | ORIGNDA050718 | approved | openfda |
| ORIGNDA020498 |
| approved |
| openfda |
| openfda |
| withdrawnsource: Cancelled Post Marketsince May 22, 2001 |
| health-canada-dpd |
| Dec 31, 1994 | Carboplatin | Health Canada CA | cancer not stated in this record | Marketed in Canada as CARBOPLATIN INJECTION (DIN 02125439) under ATC L01XA02 CARBOPLATIN. Indications are not published in the Drug Product… | DIN02125439 | approvedsource: Marketed | health-canada-dpd |
| Dec 31, 1994 | Tamoxifen | Health Canada CA | cancer not stated in this record | Marketed in Canada as NOLVADEX TAB 10MG (DIN 02048477) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product… | DIN02048477 | withdrawnsource: Cancelled Post Marketsince Apr 1, 2003 | health-canada-dpd |
| Dec 31, 1994 | Bacillus Calmette-Guerin (bcg) Substrain Montreal | Health Canada CA | cancer not stated in this record | Marketed in Canada as PACIS (DIN 02130947) under ATC L03AX03 BCG VACCINE. Indications are not published in the Drug Product Database — see… | DIN02130947 | withdrawnsource: Cancelled Post Marketsince Dec 2, 2005 | health-canada-dpd |
| Dec 31, 1994 | Tamoxifen | Health Canada CA | cancer not stated in this record | Marketed in Canada as MYLAN-TAMOXIFEN (DIN 02089858) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product… | DIN02089858 | withdrawnsource: Cancelled Post Marketsince Jan 9, 2017 | health-canada-dpd |
| Dec 31, 1994 | Tamoxifen | Health Canada CA | cancer not stated in this record | Marketed in Canada as MYLAN-TAMOXIFEN (DIN 02088428) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product… | DIN02088428 | withdrawnsource: Cancelled Post Marketsince Jan 9, 2017 | health-canada-dpd |
| Dec 31, 1994 | Etoposide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ETOPOSIDE INJECTION (DIN 02080036) under ATC L01CB01 ETOPOSIDE. Indications are not published in the Drug Product… | DIN02080036 | approvedsource: Marketed | health-canada-dpd |
| Dec 31, 1994 | Goserelin | Health Canada CA | cancer not stated in this record | Marketed in Canada as ZOLADEX (DIN 02049325) under ATC L02AE03 GOSERELIN. Indications are not published in the Drug Product Database — see… | DIN02049325 | approvedsource: Marketed | health-canada-dpd |
| Dec 31, 1994 | Vinorelbine | Health Canada CA | cancer not stated in this record | Marketed in Canada as NAVELBINE (DIN 02091283) under ATC L01CA04 VINORELBINE. Indications are not published in the Drug Product Database —… | DIN02091283 | withdrawnsource: Cancelled Post Marketsince Oct 1, 2012 | health-canada-dpd |
| Dec 31, 1994 | Nilutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ANANDRON TAB 50MG (DIN 01989642) under ATC L02BB02 NILUTAMIDE. Indications are not published in the Drug Product… | DIN01989642 | withdrawnsource: Cancelled Post Marketsince Aug 11, 1999 | health-canada-dpd |
| Dec 19, 1994 | Filgrastim | FDA US | cancer not stated in this record | Efficacy supplement 1994-12-19 (see label) | SUPPLBLA103353 | approved | openfda |
| withdrawnsource: Cancelled Post Marketsince Oct 2, 2000 |
| health-canada-dpd |