Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040525
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 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 |
---|---|---|---|---|---|---|---|
10/23/2003 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/31/2017 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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12/06/2012 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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12/06/2012 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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10/23/2003 | SUPPL-1 |
Label is not available on this site. |