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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Feb 1, 1994 | Pegaspargase | FDA US | Acute Lymphoblastic Leukemia | First-line acute lymphoblastic leukemia | ORIGBLA103411 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1993 | Buserelin | Health Canada CA | cancer not stated in this record | Marketed in Canada as SUPREFACT LIQ 1MG/ML (DIN 01989669) under ATC L02AE01 BUSERELIN. Indications are not published in the Drug Product… | DIN01989669 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 29, 1993 | Pentostatin | FDA US | cancer not stated in this record | Efficacy supplement 1993-09-29 (see label) | SUPPLNDA020122 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 23, 1993 | Interferon Beta-1b | FDA US | cancer not stated in this record | BETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome,… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1992 | Nilutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ANANDRON TAB 100MG (DIN 01989650) under ATC L02BB02 NILUTAMIDE. Indications are not published in the Drug Product… | DIN01989650 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 5, 1992 | Aldesleukin | FDA US | Melanoma | The treatment of adults with metastatic melanoma. | ORIGBLA103293 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 29, 1992 | Amphotericin B | FDA US | cancer not stated in this record | INDICATIONS & USAGE Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1991 | Diethylstilbestrol | Health Canada CA | cancer not stated in this record | Marketed in Canada as STILBESTROL 1.0MG TABLET (DIN 01904434) under ATC L02AA01 DIETHYLSTILBESTROL. Indications are not published in the… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 11, 1991 | Pentostatin | FDA US | Hairy Cell Leukemia | NIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 20, 1991 | Filgrastim | FDA US | cancer not stated in this record | NEUPOGEN is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1990 | Bacillus Calmette-Guerin (bcg) Substrain Connaught | Health Canada CA | cancer not stated in this record | Marketed in Canada as IMMUCYST (DIN 02194376) under ATC L03AX03 BCG VACCINE. Indications are not published in the Drug Product Database —… |
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 28, 2000 |
| health-canada-dpd |
| Dec 31, 1993 | Paclitaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as TAXOL (DIN 02016796) under ATC L01CD01 PACLITAXEL. Indications are not published in the Drug Product Database — see… | DIN02016796 | withdrawnsource: Cancelled Post Marketsince Jul 20, 2012 | health-canada-dpd |
| Dec 31, 1993 | Estramustine | Health Canada CA | cancer not stated in this record | Marketed in Canada as EMCYT CAP 140MG (DIN 01990934) under ATC L01XX11 ESTRAMUSTINE. Indications are not published in the Drug Product… | DIN01990934 | withdrawnsource: Cancelled Post Marketsince Sep 10, 1996 | health-canada-dpd |
| Dec 31, 1993 | Fluorouracil | Health Canada CA | cancer not stated in this record | Marketed in Canada as FLUOROURACIL INJ 50MG/ML (DIN 00891754) under ATC L01BC02 FLUOROURACIL. Indications are not published in the Drug… | DIN00891754 | withdrawnsource: Cancelled Post Marketsince Sep 10, 1996 | health-canada-dpd |
| Dec 31, 1993 | Interferon Alpha-2a | Health Canada CA | cancer not stated in this record | Marketed in Canada as ROFERON-A SOLUTION INJ. 9MILLION I.U./0.9ML (DIN 02019914) under ATC L03AB04 INTERFERON ALFA-2A. Indications are not… | DIN02019914 | withdrawnsource: Cancelled Post Marketsince Aug 26, 1997 | health-canada-dpd |
| Dec 31, 1993 | Fludarabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as FLUDARA (DIN 01989537) under ATC L01BB05 FLUDARABINE. Indications are not published in the Drug Product Database —… | DIN01989537 | withdrawnsource: Cancelled Post Marketsince Mar 31, 2011 | health-canada-dpd |
| Dec 31, 1993 | Cladribine | Health Canada CA | cancer not stated in this record | Marketed in Canada as LEUSTATIN 1MG/ML (DIN 02022117) under ATC L01BB04 CLADRIBINE. Indications are not published in the Drug Product… | DIN02022117 | withdrawnsource: Cancelled Post Marketsince Dec 19, 2011 | health-canada-dpd |
| Dec 31, 1993 | Pentostatin | Health Canada CA | cancer not stated in this record | Marketed in Canada as NIPENT PWS 10MG/VIAL (DIN 02011247) under ATC L01XX08 PENTOSTATIN. Indications are not published in the Drug Product… | DIN02011247 | withdrawnsource: Cancelled Post Marketsince Aug 25, 1997 | health-canada-dpd |
| Dec 31, 1993 | Diethylstilbestrol | Health Canada CA | cancer not stated in this record | Marketed in Canada as STILBESTROL 0.5MG TABLET (DIN 01904426) under ATC L02AA01 DIETHYLSTILBESTROL. Indications are not published in the… | DIN01904426 | withdrawnsource: Cancelled Post Marketsince Jul 30, 1998 | health-canada-dpd |
| ORIGBLA103471 |
| approved |
| openfda |
| Apr 16, 1993 | Leuprolide | FDA US | Conventional Osteosarcoma | LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP). LUPRON DEPOT-PED is a… | ORIGNDA020263 | approved | openfda |
| withdrawnsource: Cancelled Post Marketsince Aug 11, 1999 |
| health-canada-dpd |
| Dec 31, 1992 | Carboplatin | Health Canada CA | cancer not stated in this record | Marketed in Canada as CARBOPLATIN INJECTION LIQ 10MG/ML (DIN 01990438) under ATC L01XA02 CARBOPLATIN. Indications are not published in the… | DIN01990438 | withdrawnsource: Cancelled Post Marketsince Aug 13, 1998 | health-canada-dpd |
| Dec 31, 1992 | Leuprolide | Health Canada CA | cancer not stated in this record | Marketed in Canada as LUPRON DEPOT (DIN 00884502) under ATC L02AE02 LEUPRORELIN. Indications are not published in the Drug Product Database… | DIN00884502 | approvedsource: Marketed | health-canada-dpd |
| Dec 31, 1992 | Interferon Alpha-N1 | Health Canada CA | cancer not stated in this record | Marketed in Canada as WELLFERON INJ 3000000UNIT/ML (DIN 01959077) under ATC L03AB06 INTERFERON ALFA-N1. Indications are not published in… | DIN01959077 | withdrawnsource: Cancelled Post Marketsince Aug 1, 2000 | health-canada-dpd |
| Dec 31, 1992 | Interferon Alpha-N1 | Health Canada CA | cancer not stated in this record | Marketed in Canada as WELLFERON INJ 10 000 000UNIT/ML (DIN 01959069) under ATC L03AB06 INTERFERON ALFA-N1. Indications are not published in… | DIN01959069 | withdrawnsource: Cancelled Post Marketsince Aug 1, 2000 | health-canada-dpd |
| Dec 31, 1992 | Fluorouracil | Health Canada CA | cancer not stated in this record | Marketed in Canada as FLUOROPLEX CREAM 1% (DIN 01982311) under ATC L01BC02 FLUOROURACIL. Indications are not published in the Drug Product… | DIN01982311 | withdrawnsource: Cancelled Post Marketsince Aug 4, 2011 | health-canada-dpd |
| Dec 31, 1992 | Vinblastine | Health Canada CA | cancer not stated in this record | Marketed in Canada as VINBLASTINE SULFATE INJ 1MG/ML (DIN 01977784) under ATC L01CA01 VINBLASTINE. Indications are not published in the… | DIN01977784 | withdrawnsource: Cancelled Post Marketsince Aug 13, 1998 | health-canada-dpd |
| Dec 31, 1992 | Interferon Alpha-2a | Health Canada CA | cancer not stated in this record | Marketed in Canada as ROFERON-A SOLUTION INJ 36000000UNIT/ML (DIN 00891002) under ATC L03AB04 INTERFERON ALFA-2A. Indications are not… | DIN00891002 | withdrawnsource: Cancelled Post Marketsince Jun 18, 1997 | health-canada-dpd |
| Dec 31, 1992 | Tamoxifen | Health Canada CA | cancer not stated in this record | Marketed in Canada as TAMOPLEX TAB 20MG (DIN 01951947) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product… | DIN01951947 | withdrawnsource: Cancelled Post Marketsince Sep 9, 1996 | health-canada-dpd |
| Dec 31, 1992 | Tamoxifen | Health Canada CA | cancer not stated in this record | Marketed in Canada as TAMOPLEX TAB 10MG (DIN 01951939) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product… | DIN01951939 | withdrawnsource: Cancelled Post Marketsince Sep 9, 1996 | health-canada-dpd |
| Dec 31, 1992 | Nilutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ANANDRON TAB 100MG (DIN 00863904) under ATC L02BB02 NILUTAMIDE. Indications are not published in the Drug Product… | DIN00863904 | withdrawnsource: Cancelled Post Marketsince Sep 9, 1996 | health-canada-dpd |
| Dec 31, 1992 | Nilutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ANANDRON TAB 50MG (DIN 00863890) under ATC L02BB02 NILUTAMIDE. Indications are not published in the Drug Product… | DIN00863890 | withdrawnsource: Cancelled Post Marketsince Sep 9, 1996 | health-canada-dpd |
| Dec 31, 1992 | Cytarabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as CYTARABINE INJ 100MG/ML (DIN 00885797) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug… | DIN00885797 | withdrawnsource: Cancelled Post Marketsince Aug 13, 1998 | health-canada-dpd |
| Dec 31, 1992 | Filgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as NEUPOGEN (DIN 01968017) under ATC L03AA02 FILGRASTIM. Indications are not published in the Drug Product Database —… | DIN01968017 | approvedsource: Marketed | health-canada-dpd |
| Dec 31, 1992 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE SODIUM INJ 25MG/ML USP (DIN 01911457) under ATC L01BA01 METHOTREXATE. Indications are not published in… | DIN01911457 | withdrawnsource: Cancelled Post Marketsince Aug 10, 1999 | health-canada-dpd |
| May 5, 1992 | Aldesleukin | FDA US | Renal Cell Carcinoma | The treatment of adults with metastatic renal cell carcinoma. | ORIGBLA103293 | approved | openfda |
| ORIGANDA063206 |
| approved |
| openfda |
| withdrawnsource: Cancelled Post Marketsince Sep 10, 1996 |
| health-canada-dpd |
| Dec 31, 1991 | Idarubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as IDAMYCIN PWS 5MG/VIAL (DIN 01905074) under ATC L01DB06 IDARUBICIN. Indications are not published in the Drug Product… | DIN01905074 | withdrawnsource: Cancelled Post Marketsince Sep 10, 1996 | health-canada-dpd |
| Dec 31, 1991 | Idarubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as IDAMYCIN PWS 10MG/VIAL (DIN 01905066) under ATC L01DB06 IDARUBICIN. Indications are not published in the Drug Product… | DIN01905066 | withdrawnsource: Cancelled Post Marketsince Sep 10, 1996 | health-canada-dpd |
| Dec 31, 1991 | Interferon Alpha-2a | Health Canada CA | cancer not stated in this record | Marketed in Canada as ROFERON A STERILE PWS 9M UNIT/VIAL (DIN 01911996) under ATC L03AB04 INTERFERON ALFA-2A. Indications are not published… | DIN01911996 | withdrawnsource: Cancelled Post Marketsince Sep 30, 1996 | health-canada-dpd |
| Dec 31, 1991 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE TAB 2.5MG USP (DIN 00632619) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug… | DIN00632619 | withdrawnsource: Cancelled Post Marketsince Aug 1, 2000 | health-canada-dpd |
| Dec 31, 1991 | Interferon Alpha-2a | Health Canada CA | cancer not stated in this record | Marketed in Canada as ROFERON A STERILE PWS 18M UNIT/VIAL (DIN 01912003) under ATC L03AB04 INTERFERON ALFA-2A. Indications are not… | DIN01912003 | withdrawnsource: Cancelled Post Marketsince Sep 30, 1996 | health-canada-dpd |
| Dec 31, 1991 | Interferon Alpha-2a | Health Canada CA | cancer not stated in this record | Marketed in Canada as ROFERON A STERILE PWS 3M UNIT/VIAL (DIN 01911988) under ATC L03AB04 INTERFERON ALFA-2A. Indications are not published… | DIN01911988 | withdrawnsource: Cancelled Post Marketsince Sep 30, 1996 | health-canada-dpd |
| Dec 30, 1991 | 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… | ORIGNDA019839 | approved | openfda |
| ORIGNDA020122 |
| approved |
| openfda |
| ORIGBLA103353 |
| approved |
| openfda |
| Feb 20, 1991 | Filgrastim | FDA US | Acute Myeloid Leukemia | Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients… | ORIGBLA103353 | approved | openfda |
| DIN02194376 |
| withdrawnsource: Cancelled Post Marketsince Jan 31, 2018 |
| health-canada-dpd |
| Dec 31, 1990 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE SOD INJ 25MG/ML USP (DIN 02084481) under ATC L01BA01 METHOTREXATE. Indications are not published in the… | DIN02084481 | withdrawnsource: Cancelled Post Marketsince Aug 13, 1998 | health-canada-dpd |
| Dec 31, 1990 | Bacillus Calmette-Guerin BCG | Health Canada CA | cancer not stated in this record | Marketed in Canada as BCG THERAPEUTIC (DIN 00884308) under ATC L03AX03 BCG VACCINE. Indications are not published in the Drug Product… | DIN00884308 | withdrawnsource: Cancelled Post Marketsince Dec 3, 1999 | health-canada-dpd |
| Dec 31, 1990 | Tamoxifen | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEVA-TAMOXIFEN (DIN 00851973) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database… | DIN00851973 | approvedsource: Marketed | health-canada-dpd |
| Dec 31, 1990 | Tamoxifen | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEVA-TAMOXIFEN (DIN 00851965) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database… | DIN00851965 | approvedsource: Marketed | health-canada-dpd |
| Dec 31, 1990 | Cyclophosphamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as CYTOXAN PWS FOR INJ 2000MG/VIAL (DIN 00602949) under ATC L01AA01 CYCLOPHOSPHAMIDE. Indications are not published in… | DIN00602949 | withdrawnsource: Cancelled Post Marketsince Oct 17, 2008 | health-canada-dpd |