Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088468
Company: PLIVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG 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
05/01/1984 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-38 Labeling-Package Insert

Label is not available on this site.

09/11/2014 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

03/06/2015 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

10/11/2001 SUPPL-14 Labeling

Label is not available on this site.

06/08/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/2001 SUPPL-12 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

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

Label is not available on this site.

05/11/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/09/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/25/1988 SUPPL-8 Labeling

Label is not available on this site.

06/09/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/11/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/21/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/22/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/18/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/18/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

HYDRALAZINE HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 200737 ALKEM LABS LTD
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 203845 CADILA PHARMS LTD
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 090527 GLENMARK PHARMS LTD
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 086242 HERITAGE PHARMS INC
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 040901 HETERO LABS LTD III
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 090255 INVAGEN PHARMS
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 086962 PAR PHARM
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 088468 PLIVA
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 205236 SCIEGEN PHARMS INC
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 200770 STRIDES PHARMA
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 209251 UPSHER SMITH LABS

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