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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089098
Company: PLIVA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription AA 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
12/18/1985 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
01/29/2013 SUPPL-33 Labeling-Package Insert

Label is not available on this site.
09/11/2014 SUPPL-32 Labeling-Package Insert

Label is not available on this site.
11/01/2010 SUPPL-23 Labeling

Label is not available on this site.
10/11/2001 SUPPL-8 Labeling

Label is not available on this site.
05/29/2001 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.
06/15/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
07/07/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.
05/11/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
04/23/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

HYDRALAZINE HYDROCHLORIDE

TABLET;ORAL; 100MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AA 200737 ALKEM LABS LTD
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AA 203845 CADILA PHARMS LTD
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AA 090527 GLENMARK PHARMS LTD
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AA 040858 HERITAGE PHARMS INC
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AA 040901 HETERO LABS LTD III
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AA 089098 PLIVA
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AA 205236 SCIEGEN PHARMS
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AA 200770 STRIDES PHARMA
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