Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086242
Company: HERITAGE PHARMS INC
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
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription AA No No
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription AA No No
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG 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
10/23/1978 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
02/04/2010 SUPPL-29 Labeling

Label is not available on this site.

03/04/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/07/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/31/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/12/1989 SUPPL-14 Labeling

Label is not available on this site.

10/02/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/17/1983 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/10/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/18/1982 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/18/1982 SUPPL-4 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

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

TABLET;ORAL; 25MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 200737 ALKEM LABS LTD
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 203845 CADILA PHARMS LTD
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 090527 GLENMARK PHARMS LTD
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 086242 HERITAGE PHARMS INC
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 040901 HETERO LABS LTD III
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 090255 INVAGEN PHARMS
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 086961 PAR PHARM
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 088467 PLIVA
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 205236 SCIEGEN PHARMS INC
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 200770 STRIDES PHARMA
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 209251 UPSHER SMITH LABS

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 086242 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 090255 INVAGEN PHARMS
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AA 088391 PAR PHARM
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 INC
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AA 200770 STRIDES PHARMA
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AA 209251 UPSHER SMITH LABS

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