Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088618
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 No 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.

03/30/2016 SUPPL-45 Labeling-Package Insert

Label is not available on this site.

03/29/2016 SUPPL-44 Labeling-Package Insert

Label is not available on this site.

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.

01/30/2002 SUPPL-12 Labeling

Label is not available on this site.

07/07/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

02/06/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/06/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/11/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/24/1994 SUPPL-6 Labeling

Label is not available on this site.

01/14/1991 SUPPL-5 Labeling

Label is not available on this site.

08/01/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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 040804 ECI PHARMS LLC
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040604 EPIC PHARMA LLC
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 040812 INVAGEN PHARMS
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 No AB 088618 PLIVA
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040574 PRINSTON INC

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