Drugs@FDA: FDA-Approved Drugs
Company: PLIVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
01/10/1986 | 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-47 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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03/30/2016 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
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03/29/2016 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
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06/05/2014 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/088617Orig1s043,088618Orig1s043,088619Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/088617Orig1s043,088618Orig1s043,088619Orig1s044ltr.pdf | |
08/05/2008 | SUPPL-28 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/088617s030,088618s028,088619s031lbl.pdf | |
02/04/2004 | SUPPL-18 | Labeling |
Label is not available on this site. |
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01/30/2002 | SUPPL-12 | Labeling |
Label is not available on this site. |
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07/07/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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02/06/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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02/06/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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05/11/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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05/24/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
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01/14/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
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08/01/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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02/05/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/11/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/05/2014 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/088617Orig1s043,088618Orig1s043,088619Orig1s044lbl.pdf | |
08/05/2008 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/088617s030,088618s028,088619s031lbl.pdf |
HYDROXYZINE HYDROCHLORIDE
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040808 | AMNEAL PHARM |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 087871 | AUROBINDO PHARMA LTD |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040804 | CHARTWELL RX |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040604 | EPIC PHARMA LLC |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 217652 | GRAVITI PHARMS |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 204279 | HERITAGE PHARMA |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040805 | HETERO LABS LTD III |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040786 | KVK TECH |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040840 | NORTHSTAR HLTHCARE |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040842 | NORTHSTAR HLTHCARE |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 207121 | NUVO PHARMS INC |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 088618 | PLIVA |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040580 | PRINSTON INC |