Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 205236
Company: SCIEGEN 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 25MG TABLET;ORAL Prescription AA No No
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG 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
05/26/2017 ORIG-1 Approval STANDARD

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; 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; 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; 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English