Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
12/14/1981 | 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 |
---|---|---|---|---|---|
02/16/2021 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
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02/16/2021 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
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01/24/2015 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
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06/27/2013 | SUPPL-31 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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12/20/2002 | SUPPL-23 | Labeling |
Label is not available on this site. |
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02/02/2000 | SUPPL-22 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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06/24/1996 | SUPPL-21 | Labeling |
Label is not available on this site. |
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04/12/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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05/22/1996 | SUPPL-19 | Labeling |
Label is not available on this site. |
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12/09/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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03/03/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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03/03/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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08/12/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
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12/12/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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12/09/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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12/12/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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05/09/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
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03/07/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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03/07/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
HYDROXYZINE PAMOATE
CAPSULE;ORAL; EQ 25MG HYDROCHLORIDE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 088496 | BARR |
HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 201507 | HERITAGE PHARMA |
HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 040156 | IMPAX LABS INC |
HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 087479 | SANDOZ |
VISTARIL | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | Yes | AB | 011459 | PFIZER |