Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087822
Company: KV PHARM
Company: KV PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 100MG | TABLET;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 |
---|---|---|---|---|---|---|---|
06/23/1982 | 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 |
---|---|---|---|---|---|
07/11/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
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09/02/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
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04/05/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |