Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080643
Company: ROXANE
Company: ROXANE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 12.5MG/5ML | ELIXIR;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 |
---|---|---|---|---|---|---|---|
12/20/1972 | 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 |
---|---|---|---|---|---|
04/07/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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08/28/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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12/31/1990 | SUPPL-11 | Labeling |
Label is not available on this site. |
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11/23/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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12/01/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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12/01/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |