Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087836
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AA 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
10/05/1982 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
12/11/2001 SUPPL-11 Labeling

Label is not available on this site.

11/04/1988 SUPPL-10 Labeling

Label is not available on this site.

07/14/1988 SUPPL-9 Labeling

Label is not available on this site.

05/07/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/10/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

HYDRALAZINE HYDROCHLORIDE

TABLET;ORAL; 10MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 200737 ALKEM LABS LTD
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 090527 GLENMARK PHARMS LTD
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 086242 HERITAGE PHARMS INC
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 040901 HETERO LABS LTD III
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 090255 INVAGEN PHARMS
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 087836 PAR PHARM
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 089097 PLIVA
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 205236 SCIEGEN PHARMS INC
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 200770 STRIDES PHARMA
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 209251 UPSHER SMITH LABS

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