Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075252
Company: AAIPHARMA LLC
Company: AAIPHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AZASAN | AZATHIOPRINE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| AZASAN | AZATHIOPRINE | 25MG | TABLET;ORAL | Prescription | AB | No | No |
| AZASAN | AZATHIOPRINE | 75MG | TABLET;ORAL | Prescription | AB | No | No |
| AZASAN | 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 |
|---|---|---|---|---|---|---|---|
| 06/07/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75252ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/28/2023 | SUPPL-23 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/11/2022 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/02/2015 | SUPPL-18 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/02/2015 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/13/2006 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/02/2006 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 02/03/2003 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/03/2003 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/03/2003 | SUPPL-9 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 02/03/2003 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/03/2003 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/03/2003 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/03/2003 | SUPPL-5 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 08/14/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/18/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/18/2001 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/20/2000 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
AZASAN
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; 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; 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 |