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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Jul 30, 1997 | Doxorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP (DIN 02194465) under ATC L01DB01 DOXORUBICIN. Indications are not… | DIN02194465 | approvedsource: Marketed | health-canada-dpd |
| Jul 25, 1997 | Letrozole | FDA US | Malignant Breast Neoplasm | First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer. | ORIGNDA020726 | approved | openfda |
| Jul 25, 1997 | Letrozole | FDA US | Malignant Breast Neoplasm | Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy. | ORIGNDA020726 | approved | openfda |
| Jul 25, 1997 | Letrozole | FDA US | Malignant Breast Neoplasm | Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. | ORIGNDA020726 | approved | openfda |
| Jul 8, 1997 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 1997-07-08 (see label) | SUPPLNDA019839 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 30, 1997 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 1997-05-30 (see label) | SUPPLNDA020517 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 25, 1997 | Interferon Alpha-2a | Health Canada CA | cancer not stated in this record | Marketed in Canada as ROFERON-A SOLN-LIQ IM SC 9MILLION I.U./ML (DIN 02217058) under ATC L03AB04 INTERFERON ALFA-2A. Indications are not… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 14, 1997 | Anagrelide | FDA US | Myeloproliferative Neoplasm | AGRYLIN is indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 27, 1997 | Megestrol | Health Canada CA | cancer not stated in this record | Marketed in Canada as MEGESTROL-160 - TAB 160 MG (DIN 02223112) under ATC L02AB01 MEGESTROL. Indications are not published in the Drug… | DIN02223112 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 29, 1997 | Leuprolide | Health Canada CA | cancer not stated in this record | Marketed in Canada as LUPRON DEPOT (DIN 02230248) under ATC L02AE02 LEUPRORELIN. Indications are not published in the Drug Product Database… | DIN02230248 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 31, 1996 | Flutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as FLUTAMIDE (DIN 02059673) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database —… | DIN02059673 |
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.
| May 29, 1997 | Toremifene | FDA US | Malignant Breast Neoplasm | FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with… | ORIGNDA020497 | approved | openfda |
| May 29, 1997 | Topotecan | Health Canada CA | cancer not stated in this record | Marketed in Canada as HYCAMTIN (DIN 02231116) under ATC L01CE01 TOPOTECAN. Indications are not published in the Drug Product Database — see… | DIN02231116 | withdrawnsource: Cancelled Post Marketsince Mar 18, 2019 | health-canada-dpd |
| May 9, 1997 | Cisplatin | Health Canada CA | cancer not stated in this record | Marketed in Canada as CISPLATIN INJECTION BP (DIN 02126613) under ATC L01XA01 CISPLATIN. Indications are not published in the Drug Product… | DIN02126613 | approvedsource: Marketed | health-canada-dpd |
| May 8, 1997 | Doxorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP (DIN 02194473) under ATC L01DB01 DOXORUBICIN. Indications are not… | DIN02194473 | approvedsource: Marketed | health-canada-dpd |
| withdrawnsource: Cancelled Post Marketsince Nov 1, 2004 |
| health-canada-dpd |
| Apr 25, 1997 | Interferon Alpha-2a | Health Canada CA | cancer not stated in this record | Marketed in Canada as ROFERON-A SOLN-LIQ IM SC 4.5MILLION I.U/ML (DIN 02217023) under ATC L03AB04 INTERFERON ALFA-2A. Indications are not… | DIN02217023 | withdrawnsource: Cancelled Post Marketsince Nov 2, 1999 | health-canada-dpd |
| Apr 15, 1997 | Topotecan | EMA EU | Ovarian Carcinoma | Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent… | centralisedEMEA/H/C/000124 | withdrawn | ema |
| Apr 1, 1997 | Diethylstilbestrol | Health Canada CA | cancer not stated in this record | Marketed in Canada as STILBESTROL TABLETS 0.5 MG (DIN 02100304) under ATC L02AA01 DIETHYLSTILBESTROL. Indications are not published in the… | DIN02100304 | withdrawnsource: Cancelled Post Marketsince Feb 23, 2009 | health-canada-dpd |
| ORIGNDA020333 |
| approved |
| openfda |
| Mar 12, 1997 | Interferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as INTRON A (DIN 02223406) under ATC L03AB05 INTERFERON ALFA-2B. Indications are not published in the Drug Product… | DIN02223406 | withdrawnsource: Cancelled Post Marketsince Nov 10, 2021 | health-canada-dpd |
| Mar 10, 1997 | Gemcitabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as GEMZAR (1GM/VIAL) (DIN 02230309) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product… | DIN02230309 | withdrawnsource: Cancelled Post Marketsince Nov 1, 2015 | health-canada-dpd |
| Mar 10, 1997 | Gemcitabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as GEMZAR (200MG/VIAL) (DIN 02230308) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product… | DIN02230308 | withdrawnsource: Cancelled Post Marketsince Mar 11, 2015 | health-canada-dpd |
| Mar 7, 1997 | Leuprolide | FDA US | cancer not stated in this record | Endometriosis Management of endometriosis, including pain relief and reduction of endometriotic lesions. • In combination with a… | ORIGNDA020708 | approved | openfda |
| withdrawnsource: Cancelled Post Marketsince Jul 13, 2010 |
| health-canada-dpd |
| Feb 27, 1997 | Megestrol | Health Canada CA | cancer not stated in this record | Marketed in Canada as MEGESTROL-40 - TAB 40MG (DIN 02223104) under ATC L02AB01 MEGESTROL. Indications are not published in the Drug Product… | DIN02223104 | withdrawnsource: Cancelled Post Marketsince Jul 13, 2010 | health-canada-dpd |
| Feb 25, 1997 | Interferon Alpha-2a | Health Canada CA | cancer not stated in this record | Marketed in Canada as ROFERON-A SOLUTION 3 MILLION I.U./ML (DIN 02217015) under ATC L03AB04 INTERFERON ALFA-2A. Indications are not… | DIN02217015 | withdrawnsource: Cancelled Post Marketsince Jul 14, 2005 | health-canada-dpd |
| Feb 24, 1997 | Interferon Alpha-2a | Health Canada CA | cancer not stated in this record | Marketed in Canada as ROFERON-A SOLUTION 6 MILLION I.U./ML (DIN 02217031) under ATC L03AB04 INTERFERON ALFA-2A. Indications are not… | DIN02217031 | withdrawnsource: Cancelled Post Marketsince Jul 27, 2000 | health-canada-dpd |
| Feb 21, 1997 | Flutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as PMS-FLUTAMIDE (DIN 02230104) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database… | DIN02230104 | withdrawnsource: Cancelled Post Marketsince Jul 4, 2025 | health-canada-dpd |
| Feb 17, 1997 | Idarubicin | FDA US | Acute Myeloid Leukemia | IDAMYCIN PFS is indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination… | ORIGNDA050734 | approved | openfda |
| Feb 10, 1997 | Buserelin | Health Canada CA | cancer not stated in this record | Marketed in Canada as SUPREFACT DEPOT 2 MONTHS (DIN 02228955) under ATC L02AE01 BUSERELIN. Indications are not published in the Drug… | DIN02228955 | withdrawnsource: Dormantsince Nov 1, 2025 | health-canada-dpd |
| Feb 7, 1997 | Tretinoin | FDA US | cancer not stated in this record | RETIN-A MICRO ® is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. RETIN-A… | ORIGNDA020475 | approved | openfda |
| Feb 4, 1997 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE-LIQ IM IV IAR INT IVR 25MG/ML (DIN 02170663) under ATC L01BA01 METHOTREXATE. Indications are not… | DIN02170663 | withdrawnsource: Cancelled Post Marketsince Sep 19, 2001 | health-canada-dpd |
| Feb 4, 1997 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE-PWS IM IV IAR INT IVR 20MG/VIAL (DIN 02170655) under ATC L01BA01 METHOTREXATE. Indications are not… | DIN02170655 | withdrawnsource: Cancelled Post Marketsince May 22, 2001 | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Jan 28, 1997 | Etoposide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ETOPOSIDE - LIQ IV 20MG/ML (DIN 02227509) under ATC L01CB01 ETOPOSIDE. Indications are not published in the Drug… | DIN02227509 | withdrawnsource: Cancelled Post Marketsince Jul 1, 1998 | health-canada-dpd |
| Jan 24, 1997 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE (DIN 02170671) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product… | DIN02170671 | withdrawnsource: Cancelled Post Marketsince May 3, 2011 | health-canada-dpd |
| Jan 16, 1997 | Flutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEVA-FLUTAMIDE (DIN 02230089) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database… | DIN02230089 | withdrawnsource: Cancelled Post Marketsince Apr 30, 2018 | health-canada-dpd |
| Jan 15, 1997 | Interferon Alpha-2a | Health Canada CA | cancer not stated in this record | Marketed in Canada as ROFERON-A SOLUTION 18 MILLION I.U./3ML (DIN 02217066) under ATC L03AB04 INTERFERON ALFA-2A. Indications are not… | DIN02217066 | withdrawnsource: Cancelled Post Marketsince Jul 14, 2005 | health-canada-dpd |
| Jan 14, 1997 | Tretinoin | FDA US | cancer not stated in this record | Tretinoin Cream, USP is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of this product in the… | ORIGNDA020404 | approved | openfda |
| withdrawnsource: Cancelled Post Marketsince Jul 31, 2014 |
| health-canada-dpd |
| Dec 31, 1996 | Doxorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as ADRIAMYCIN RDF (DIN 02065657) under ATC L01DB01 DOXORUBICIN. Indications are not published in the Drug Product… | DIN02065657 | withdrawnsource: Cancelled Post Marketsince Aug 2, 2006 | health-canada-dpd |
| Dec 31, 1996 | Idarubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as IDAMYCIN - CAP 5MG (DIN 02166100) under ATC L01DB06 IDARUBICIN. Indications are not published in the Drug Product… | DIN02166100 | withdrawnsource: Cancelled Post Marketsince Aug 2, 2006 | health-canada-dpd |
| Dec 31, 1996 | Idarubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as IDAMYCIN - CAP 10MG (DIN 02166119) under ATC L01DB06 IDARUBICIN. Indications are not published in the Drug Product… | DIN02166119 | withdrawnsource: Cancelled Post Marketsince Aug 2, 2006 | health-canada-dpd |
| Dec 31, 1996 | Tamoxifen | Health Canada CA | cancer not stated in this record | Marketed in Canada as TAMONE - (10 MG) (DIN 02063778) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product… | DIN02063778 | withdrawnsource: Cancelled Post Marketsince Oct 2, 2007 | health-canada-dpd |
| Dec 31, 1996 | Tamoxifen | Health Canada CA | cancer not stated in this record | Marketed in Canada as TAMONE - (20 MG) (DIN 02063751) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product… | DIN02063751 | withdrawnsource: Cancelled Post Marketsince Oct 2, 2007 | health-canada-dpd |
| Dec 31, 1996 | Megestrol | Health Canada CA | cancer not stated in this record | Marketed in Canada as MEGESTROL (DIN 02185423) under ATC L02AB01 MEGESTROL. Indications are not published in the Drug Product Database —… | DIN02185423 | approved | health-canada-dpd |
| Dec 31, 1996 | Megestrol | Health Canada CA | cancer not stated in this record | Marketed in Canada as MEGESTROL (DIN 02185415) under ATC L02AB01 MEGESTROL. Indications are not published in the Drug Product Database —… | DIN02185415 | approved | health-canada-dpd |
| Dec 31, 1996 | Bicalutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as CASODEX (DIN 02184478) under ATC L02BB03 BICALUTAMIDE. Indications are not published in the Drug Product Database —… | DIN02184478 | withdrawnsource: Cancelled Post Marketsince Mar 7, 2025 | health-canada-dpd |
| Dec 31, 1996 | Doxorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as ADRIAMYCIN RDF (DIN 02069563) under ATC L01DB01 DOXORUBICIN. Indications are not published in the Drug Product… | DIN02069563 | withdrawnsource: Cancelled Post Marketsince Aug 2, 2006 | health-canada-dpd |
| Dec 30, 1996 | Idarubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as IDAMYCIN - CAP 25MG (DIN 02166127) under ATC L01DB06 IDARUBICIN. Indications are not published in the Drug Product… | DIN02166127 | withdrawnsource: Cancelled Post Marketsince Aug 2, 2006 | health-canada-dpd |
| Dec 30, 1996 | Buserelin | Health Canada CA | cancer not stated in this record | Marketed in Canada as SUPREFACT (DIN 02225166) under ATC L02AE01 BUSERELIN. Indications are not published in the Drug Product Database —… | DIN02225166 | approvedsource: Marketed | health-canada-dpd |
| Dec 20, 1996 | Glatiramer | FDA US | cancer not stated in this record | COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome,… | ORIGNDA020622 | approved | openfda |
| Dec 13, 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 | ORIGNDA020267 | approved | openfda |