Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087767
Company: WATSON LABS
Company: WATSON LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | 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 |
---|---|---|---|---|---|---|---|
08/16/1982 | 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 |
---|---|---|---|---|---|
03/18/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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02/10/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
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06/07/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
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12/27/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |