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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Apr 30, 1998 | Capecitabine | FDA US | cancer not stated in this record | Gastric, Esophageal, or Gastroesophageal Junction Cancer treatment of adults with unresectable or metastatic gastric, esophageal, or… | ORIGNDA020896 | approved | openfda |
| Apr 30, 1998 | Capecitabine | FDA US | Pancreatic Adenocarcinoma | Pancreatic Cancer adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. | ORIGNDA020896 | approved | openfda |
| Apr 30, 1998 | Capecitabine | FDA US | Gastroesophageal Junction Adenocarcinoma | treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior… | ORIGNDA020896 | approved | openfda |
| Apr 30, 1998 | Capecitabine | FDA US | Malignant Breast Neoplasm | treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior… | ORIGNDA020896 | approved | openfda |
| Apr 30, 1998 | Capecitabine | FDA US | Malignant Breast Neoplasm | Breast Cancer treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing… | ORIGNDA020896 | approved | openfda |
| Apr 30, 1998 | Capecitabine | FDA US | Malignant Colorectal Neoplasm | treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy… | ORIGNDA020896 | approved | openfda |
| Apr 30, 1998 | Capecitabine | FDA US | Malignant Rectal Neoplasm | perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. | ORIGNDA020896 | approved | openfda |
| Apr 30, 1998 | Capecitabine | FDA US | Malignant Colon Neoplasm | Colorectal Cancer adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination… | ORIGNDA020896 | approved | openfda |
| Apr 14, 1998 | Vinblastine | Health Canada CA | cancer not stated in this record | Marketed in Canada as VINBLASTINE SULFATE INJECTION (DIN 02183056) under ATC L01CA01 VINBLASTINE. Indications are not published in the Drug… | DIN02183056 | approvedsource: Marketed | health-canada-dpd |
| Apr 9, 1998 | Goserelin | FDA US | cancer not stated in this record | Efficacy supplement 1998-04-09 (see label) | SUPPLNDA019726 | approved | openfda |
| Apr 9, 1998 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 1998-04-09 (see label) | SUPPLNDA020011 | approved | openfda |
| Apr 3, 1998 | Interferon Beta-1a | Health Canada CA | cancer not stated in this record | Marketed in Canada as REBIF (DIN 02237317) under ATC L03AB07 INTERFERON BETA-1A. Indications are not published in the Drug Product Database… | DIN02237317 | withdrawnsource: Cancelled Post Marketsince May 9, 2011 | health-canada-dpd |
| Apr 2, 1998 | Filgrastim | FDA US | cancer not stated in this record | Efficacy supplement 1998-04-02 (see label) | SUPPLBLA103353 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 12, 1998 | Mitomycin | Health Canada CA | cancer not stated in this record | Marketed in Canada as MITOMYCIN FOR INJECTION USP (DIN 02230729) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug… | DIN02230729 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 25, 1998 | Hydroxyurea | FDA US | cancer not stated in this record | Efficacy supplement 1998-02-25 (see label) | SUPPLNDA016295 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 30, 1998 | Ibuprofen | FDA US | cancer not stated in this record | Uses temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, headaches and toothaches | ORIGNDA020812 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 12, 1997 | Bicalutamide | FDA US | cancer not stated in this record | Efficacy supplement 1997-12-12 (see label) | SUPPLNDA020498 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 26, 1997 | Rituximab | FDA US | cancer not stated in this record | . Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular,… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 31, 1997 | Flutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as FLUTAMIDE (DIN 02230875) under ATC L02BB01 FLUTAMIDE. Indications are not published in the Drug Product Database —… | DIN02230875 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 30, 1997 | Irbesartan | FDA US | cancer not stated in this record | Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events,… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 27, 1997 | Irinotecan | Health Canada CA | cancer not stated in this record | Marketed in Canada as CAMPTOSAR (DIN 02231622) under ATC L01CE02 IRINOTECAN. Indications are not published in the Drug Product Database —… | DIN02231622 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 30, 1997 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE INJECTION USP (DIN 02182971) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug… | DIN |
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 Feb 28, 2020 |
| health-canada-dpd |
| Mar 12, 1998 | Bleomycin | Health Canada CA | cancer not stated in this record | Marketed in Canada as BLEOMYCIN FOR INJECTION USP (DIN 02131692) under ATC L01DC01 BLEOMYCIN. Indications are not published in the Drug… | DIN02131692 | approvedsource: Marketed | health-canada-dpd |
| Mar 12, 1998 | Doxorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP (DIN 02194457) under ATC L01DB01 DOXORUBICIN. Indications are not… | DIN02194457 | withdrawnsource: Cancelled Pre Marketsince May 9, 2024 | health-canada-dpd |
| Mar 11, 1998 | Interferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as INTRON A (DIN 02231651) under ATC L03AB05 INTERFERON ALFA-2B. Indications are not published in the Drug Product… | DIN02231651 | withdrawnsource: Cancelled Post Marketsince Aug 9, 2017 | health-canada-dpd |
| Mar 4, 1998 | Daunorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as DAUNORUBICIN HYDROCHLORIDE FOR INJECTION (DIN 02231420) under ATC L01DB02 DAUNORUBICIN. Indications are not published… | DIN02231420 | withdrawnsource: Cancelled Post Marketsince Apr 30, 2018 | health-canada-dpd |
| Feb 24, 1998 | Interferon Beta-1a | Health Canada CA | cancer not stated in this record | Marketed in Canada as REBIF (DIN 02237320) under ATC L03AB07 INTERFERON BETA-1A. Indications are not published in the Drug Product Database… | DIN02237320 | approvedsource: Marketed | health-canada-dpd |
| Feb 23, 1998 | Interferon Beta-1a | Health Canada CA | cancer not stated in this record | Marketed in Canada as REBIF (DIN 02237319) under ATC L03AB07 INTERFERON BETA-1A. Indications are not published in the Drug Product Database… | DIN02237319 | approvedsource: Marketed | health-canada-dpd |
| Feb 3, 1998 | Buserelin | Health Canada CA | cancer not stated in this record | Marketed in Canada as SUPREFACT (DIN 02225158) under ATC L02AE01 BUSERELIN. Indications are not published in the Drug Product Database —… | DIN02225158 | withdrawnsource: Cancelled Post Marketsince Apr 29, 2022 | health-canada-dpd |
| openfda |
| Jan 30, 1998 | Daunorubicin | FDA US | cancer not stated in this record | Daunorubicin hydrochloride in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic… | ORIGNDA050731 | approved | openfda |
| Jan 9, 1998 | Porfimer | FDA US | cancer not stated in this record | Efficacy supplement 1998-01-09 (see label) | SUPPLNDA020451 | approved | openfda |
| Jan 9, 1998 | Aldesleukin | FDA US | cancer not stated in this record | Efficacy supplement 1998-01-09 (see label) | SUPPLBLA103293 | approved | openfda |
| Jan 9, 1998 | Aldesleukin | FDA US | cancer not stated in this record | Efficacy supplement 1998-01-09 (see label) | SUPPLBLA103293 | approved | openfda |
| Jan 6, 1998 | Anagrelide | Health Canada CA | cancer not stated in this record | Marketed in Canada as AGRYLIN (DIN 02236859) under ATC L01XX35 ANAGRELIDE. Indications are not published in the Drug Product Database — see… | DIN02236859 | withdrawnsource: Cancelled Post Marketsince Feb 19, 2024 | health-canada-dpd |
| ORIGBLA103705 |
| approved |
| openfda |
| Nov 26, 1997 | Rituximab | FDA US | Non-Hodgkin Lymphoma | Adult patients with Non-Hodgkin's Lymphoma (NHL) | ORIGBLA103705 | approved | openfda |
| withdrawnsource: Cancelled Post Marketsince Oct 28, 2016 |
| health-canada-dpd |
| Oct 24, 1997 | Paclitaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as PACLITAXEL INJECTION (DIN 02231605) under ATC L01CD01 PACLITAXEL. Indications are not published in the Drug Product… | DIN02231605 | withdrawnsource: Cancelled Post Marketsince Dec 6, 2005 | health-canada-dpd |
| Oct 22, 1997 | Mitomycin | Health Canada CA | cancer not stated in this record | Marketed in Canada as MITOMYCIN FOR INJECTION (DIN 02230451) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product… | DIN02230451 | approvedsource: Marketed | health-canada-dpd |
| Oct 22, 1997 | Mitomycin | Health Canada CA | cancer not stated in this record | Marketed in Canada as MITOMYCIN FOR INJECTION (DIN 02230450) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product… | DIN02230450 | withdrawnsource: Cancelled Post Marketsince Feb 10, 2017 | health-canada-dpd |
| Oct 14, 1997 | Glatiramer | Health Canada CA | cancer not stated in this record | Marketed in Canada as COPAXONE (DIN 02233014) under ATC L03AX13 GLATIRAMER ACETATE. Indications are not published in the Drug Product… | DIN02233014 | withdrawnsource: Cancelled Post Marketsince Apr 28, 2011 | health-canada-dpd |
| Oct 10, 1997 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 1997-10-10 (see label) | SUPPLNDA019839 | approved | openfda |
| ORIGNDA020757 |
| approved |
| openfda |
| Sep 25, 1997 | Interferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as INTRON A - LIQ 5000000IU/ML (DIN 02223414) under ATC L03AB05 INTERFERON ALFA-2B. Indications are not published in the… | DIN02223414 | withdrawnsource: Cancelled Post Marketsince Jul 18, 2001 | health-canada-dpd |
| Sep 22, 1997 | Daunorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as DAUNOXOME LIPOSOMAL - IV 2MG/ML, 50MG/VIAL (DIN 02218046) under ATC L01DB02 DAUNORUBICIN. Indications are not… | DIN02218046 | withdrawnsource: Cancelled Post Marketsince Sep 21, 2001 | health-canada-dpd |
| Sep 12, 1997 | Doxorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as DOXORUBICIN HYDROCHLORIDE INJECTION (DIN 02230108) under ATC L01DB01 DOXORUBICIN. Indications are not published in… | DIN02230108 | withdrawnsource: Cancelled Post Marketsince May 2, 2018 | health-canada-dpd |
| withdrawnsource: Cancelled Post Marketsince Jun 2, 2022 |
| health-canada-dpd |
| Aug 25, 1997 | Thiotepa | Health Canada CA | cancer not stated in this record | Marketed in Canada as THIOTEPA - (PWS 15 MG/VIAL) (DIN 02174391) under ATC L01AC01 THIOTEPA. Indications are not published in the Drug… | DIN02174391 | withdrawnsource: Cancelled Post Marketsince Sep 15, 2004 | health-canada-dpd |
| Aug 20, 1997 | Nilutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ANANDRON - TAB 100MG (DIN 02221888) under ATC L02BB02 NILUTAMIDE. Indications are not published in the Drug Product… | DIN02221888 | withdrawnsource: Cancelled Post Marketsince Jul 22, 2003 | health-canada-dpd |
| Aug 20, 1997 | Nilutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ANANDRON (DIN 02221861) under ATC L02BB02 NILUTAMIDE. Indications are not published in the Drug Product Database —… | DIN02221861 | withdrawnsource: Dormantsince Aug 3, 2024 | health-canada-dpd |
| Aug 18, 1997 | Letrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as FEMARA (DIN 02231384) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see… | DIN02231384 | approvedsource: Marketed | health-canada-dpd |
| Aug 7, 1997 | Vincristine | Health Canada CA | cancer not stated in this record | Marketed in Canada as VINCRISTINE SULFATE INJECTION USP (DIN 02183013) under ATC L01CA02 VINCRISTINE. Indications are not published in the… | DIN02183013 | approvedsource: Marketed | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Jul 30, 1997 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE INJECTION USP (DIN 02182947) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug… | DIN02182947 | approvedsource: Marketed | health-canada-dpd |
| Jul 30, 1997 | Carboplatin | Health Canada CA | cancer not stated in this record | Marketed in Canada as CARBOPLATIN INJECTION BP (DIN 02126680) under ATC L01XA02 CARBOPLATIN. Indications are not published in the Drug… | DIN02126680 | approvedsource: Marketed | health-canada-dpd |