Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075568
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AZATHIOPRINE | AZATHIOPRINE | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/13/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75568ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/23/2019 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/29/2015 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/23/2011 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/28/2008 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/06/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 11/19/2003 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/04/2002 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/21/2001 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/21/2001 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
AZATHIOPRINE
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 |