Drugs@FDA: FDA-Approved Drugs
Company: AM REGENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/27/1981 | 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 |
---|---|---|---|---|---|
11/08/2016 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
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03/30/2016 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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06/03/2014 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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01/02/2003 | SUPPL-15 | Labeling |
Label is not available on this site. |
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07/17/2002 | SUPPL-14 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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09/25/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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02/28/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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12/24/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
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04/02/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
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09/04/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
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05/22/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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09/13/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |