Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077992
Company: VINTAGE
Company: VINTAGE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;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 |
---|---|---|---|---|---|---|---|
12/12/2006 | 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 |
---|---|---|---|---|---|
07/29/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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03/25/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
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05/31/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |