Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076503
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SOTRET | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 06/20/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076503.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/12/2012 | SUPPL-16 | REMS-Modified |
Label is not available on this site. |
||
| 10/22/2010 | SUPPL-7 | REMS-Proposal |
Label is not available on this site. |
||
| 03/25/2010 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/20/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/02/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/06/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 02/06/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/12/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |