Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208687
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AZATHIOPRINE | AZATHIOPRINE | 25MG | TABLET;ORAL | Prescription | AB | No | No |
AZATHIOPRINE | AZATHIOPRINE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
AZATHIOPRINE | AZATHIOPRINE | 75MG | TABLET;ORAL | Prescription | AB | No | No |
AZATHIOPRINE | AZATHIOPRINE | 100MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/27/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
AZATHIOPRINE
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZASAN | AZATHIOPRINE | 25MG | TABLET;ORAL | Prescription | No | AB | 075252 | AAIPHARMA LLC |
AZATHIOPRINE | AZATHIOPRINE | 25MG | TABLET;ORAL | Prescription | No | AB | 208687 | ALKEM LABS LTD |
AZATHIOPRINE | AZATHIOPRINE | 25MG | TABLET;ORAL | Prescription | No | AB | 077621 | ZYDUS PHARMS USA |
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZASAN | AZATHIOPRINE | 50MG | TABLET;ORAL | Prescription | No | AB | 075252 | AAIPHARMA LLC |
AZATHIOPRINE | AZATHIOPRINE | 50MG | TABLET;ORAL | Prescription | No | AB | 208687 | ALKEM LABS LTD |
AZATHIOPRINE | AZATHIOPRINE | 50MG | TABLET;ORAL | Prescription | No | AB | 074069 | AMNEAL |
AZATHIOPRINE | AZATHIOPRINE | 50MG | TABLET;ORAL | Prescription | No | AB | 075568 | RISING |
AZATHIOPRINE | AZATHIOPRINE | 50MG | TABLET;ORAL | Prescription | No | AB | 077621 | ZYDUS PHARMS USA |
IMURAN | AZATHIOPRINE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 016324 | SEBELA IRELAND LTD |
TABLET;ORAL; 75MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZASAN | AZATHIOPRINE | 75MG | TABLET;ORAL | Prescription | No | AB | 075252 | AAIPHARMA LLC |
AZATHIOPRINE | AZATHIOPRINE | 75MG | TABLET;ORAL | Prescription | No | AB | 208687 | ALKEM LABS LTD |
AZATHIOPRINE | AZATHIOPRINE | 75MG | TABLET;ORAL | Prescription | No | AB | 074069 | AMNEAL |
AZATHIOPRINE | AZATHIOPRINE | 75MG | TABLET;ORAL | Prescription | No | AB | 077621 | ZYDUS PHARMS USA |
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZASAN | AZATHIOPRINE | 100MG | TABLET;ORAL | Prescription | No | AB | 075252 | AAIPHARMA LLC |
AZATHIOPRINE | AZATHIOPRINE | 100MG | TABLET;ORAL | Prescription | No | AB | 208687 | ALKEM LABS LTD |
AZATHIOPRINE | AZATHIOPRINE | 100MG | TABLET;ORAL | Prescription | No | AB | 074069 | AMNEAL |
AZATHIOPRINE | AZATHIOPRINE | 100MG | TABLET;ORAL | Prescription | No | AB | 077621 | ZYDUS PHARMS USA |