Drugs@FDA: FDA-Approved Drugs
Company: SEBELA IRELAND LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IMURAN | AZATHIOPRINE | 50MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
IMURAN | AZATHIOPRINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
03/20/1968 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/09/2024 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/016324s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/016324Orig1s040ltr.pdf | |
12/20/2018 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016324s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/016324Orig1s039Ltr.pdf | |
11/22/2017 | SUPPL-38 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016324Orig1s038ltr.pdf | |
02/06/2014 | SUPPL-37 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016324s037,017391s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016324Orig1s037,017391Orig1s016ltr.pdf | |
05/21/2014 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/24/2011 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016324s034,s035,017391s015ltr.pdf | |
05/24/2011 | SUPPL-34 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016324s034,s035,017391s015ltr.pdf | |
07/09/2008 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016324s031,017391s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016324s031, 017391s014LTR.pdf | |
07/26/2005 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016324s030,017391s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016324s030,017391s013ltr.pdf | |
12/19/2002 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16324slr026,17391slr011ltr.pdf |
10/26/1992 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/28/1992 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/09/1992 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/18/1988 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/17/1989 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/24/1988 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/26/1987 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/30/1994 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
04/13/1981 | SUPPL-10 | Efficacy |
Label is not available on this site. |
||
03/21/1980 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/07/1978 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/09/2024 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/016324s040lbl.pdf | |
12/20/2018 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016324s039lbl.pdf | |
02/06/2014 | SUPPL-37 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016324s037,017391s016lbl.pdf | |
05/24/2011 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035lbl.pdf | |
05/24/2011 | SUPPL-34 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035lbl.pdf | |
07/09/2008 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016324s031,017391s014lbl.pdf | |
07/26/2005 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016324s030,017391s013lbl.pdf |
IMURAN
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 |