Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076041
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 | 10MG | CAPSULE;ORAL | Discontinued | None | No | No |
SOTRET | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Discontinued | None | No | No |
SOTRET | ISOTRETINOIN | 40MG | 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 |
---|---|---|---|---|---|---|---|
12/24/2002 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076041.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/12/2012 | SUPPL-18 | REMS-Modified |
Label is not available on this site. |
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10/22/2010 | SUPPL-8 | REMS-Proposal |
Label is not available on this site. |
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03/25/2010 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/20/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
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11/02/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
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02/06/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
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02/06/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
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08/12/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
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05/28/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |