Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROXYZINE | HYDROXYZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
08/24/1979 | 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 |
---|---|---|---|---|---|
07/06/2000 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/18/1997 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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07/18/1997 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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08/19/1993 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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08/06/1991 | SUPPL-30 | Labeling |
Label is not available on this site. |
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05/21/1991 | SUPPL-29 | Labeling |
Label is not available on this site. |
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04/24/1990 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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10/12/1989 | SUPPL-27 | Labeling |
Label is not available on this site. |
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05/01/1989 | SUPPL-26 | Labeling |
Label is not available on this site. |
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12/09/1988 | SUPPL-24 | Labeling |
Label is not available on this site. |
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10/17/1988 | SUPPL-22 | Labeling |
Label is not available on this site. |
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10/22/1985 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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03/27/1985 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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01/19/1984 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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09/30/1982 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |