Drugs@FDA: FDA-Approved Drugs
Company: IVAX SUB TEVA PHARMS
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 |
---|---|---|---|---|---|---|---|
03/05/1982 | 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 |
---|---|---|---|---|---|
07/29/2002 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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09/12/2001 | SUPPL-20 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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11/13/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/05/2000 | SUPPL-18 | Labeling |
Label is not available on this site. |
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01/28/2000 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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07/05/2000 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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04/30/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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04/30/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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04/30/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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12/09/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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05/30/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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10/16/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
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10/26/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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09/01/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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02/11/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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09/15/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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09/15/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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09/15/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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08/25/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |