Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090228
Company: INVAGEN PHARMS
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 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
07/09/2009 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
09/14/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/14/2015 SUPPL-2 Labeling-Package Insert

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

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