Drugs@FDA: FDA-Approved Drugs
Company: BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 100MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
06/15/1984 | 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 |
---|---|---|---|---|---|
02/16/2021 | SUPPL-52 | Labeling-Package Insert |
Label is not available on this site. |
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02/16/2021 | SUPPL-51 | Labeling-Package Insert |
Label is not available on this site. |
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01/24/2015 | SUPPL-48 | Labeling-Package Insert |
Label is not available on this site. |
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07/27/2011 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
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05/28/2008 | SUPPL-43 | Labeling |
Label is not available on this site. |
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01/03/2003 | SUPPL-33 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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04/29/2002 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/09/2001 | SUPPL-31 | Labeling |
Label is not available on this site. |
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11/09/2001 | SUPPL-30 | Labeling |
Label is not available on this site. |
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02/03/2000 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/21/1999 | SUPPL-28 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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06/11/1999 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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05/20/1999 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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11/16/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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12/01/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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11/16/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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11/16/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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09/20/1996 | SUPPL-21 | Labeling |
Label is not available on this site. |
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04/10/1996 | SUPPL-20 | Labeling |
Label is not available on this site. |
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12/23/1994 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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10/11/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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04/03/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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04/03/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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01/12/1995 | SUPPL-14 | Labeling |
Label is not available on this site. |
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01/12/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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05/09/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
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01/04/1990 | SUPPL-11 | Labeling |
Label is not available on this site. |
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09/12/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
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11/18/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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11/18/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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03/31/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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09/25/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |