Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009053
Company: STASON PHARMS
Company: STASON PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PURINETHOL | MERCAPTOPURINE | 50MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 09/11/1953 | 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 |
|---|---|---|---|---|---|
| 12/29/2020 | SUPPL-40 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009053s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/009053Orig1s040ltr.pdf | |
| 04/29/2020 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009053s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/009053Orig1s039ltr.pdf | |
| 05/23/2018 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/09053s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/009053Orig1s035ltr.pdf | |
| 05/27/2011 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009053s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009053s032ltr.pdf | |
| 07/15/2004 | SUPPL-24 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09053s024lbl.pdf | |
| 01/10/2003 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09053slr022_purinethol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09053slr022ltr.pdf | |
| 09/06/2002 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09053slr021ltr.pdf |
| 03/22/2002 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09053s020ltr.pdf |
| 04/03/2001 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/15/1996 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 05/16/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/17/1987 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/20/1987 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/09/1987 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/23/1986 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 11/20/1985 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/14/1986 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/19/1982 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/19/1979 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/15/1977 | SUPPL-6 | 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 |
|---|---|---|---|---|---|
| 12/29/2020 | SUPPL-40 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009053s040lbl.pdf | |
| 12/29/2020 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009053s040lbl.pdf | |
| 04/29/2020 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009053s039lbl.pdf | |
| 05/23/2018 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/09053s035lbl.pdf | |
| 05/27/2011 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009053s032lbl.pdf | |
| 07/15/2004 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09053s024lbl.pdf | |
| 01/10/2003 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09053slr022_purinethol_lbl.pdf |
PURINETHOL
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MERCAPTOPURINE | MERCAPTOPURINE | 50MG | TABLET;ORAL | Prescription | No | AB | 040461 | DR REDDYS LABS SA |
| MERCAPTOPURINE | MERCAPTOPURINE | 50MG | TABLET;ORAL | Prescription | No | AB | 040528 | HIKMA |
| MERCAPTOPURINE | MERCAPTOPURINE | 50MG | TABLET;ORAL | Prescription | No | AB | 040594 | MYLAN |
| PURINETHOL | MERCAPTOPURINE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 009053 | STASON PHARMS |