Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 079025
Company: EMCURE PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET;ORAL Prescription AB No No
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET;ORAL Prescription AB 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
09/17/2010 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
01/03/2014 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 10MG;12.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET;ORAL Prescription No AB 079245 AUROBINDO PHARMA
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET;ORAL Prescription No AB 079025 EMCURE PHARMS LTD
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET;ORAL Prescription No AB 090228 INVAGEN PHARMS
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET;ORAL Prescription No AB 076961 SANDOZ

TABLET;ORAL; 20MG;12.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET;ORAL Prescription No AB 079245 AUROBINDO PHARMA
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET;ORAL Prescription No AB 079025 EMCURE PHARMS LTD
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET;ORAL Prescription No AB 090228 INVAGEN PHARMS
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET;ORAL Prescription No AB 076961 SANDOZ

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