Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076139
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 10MG TABLET;ORAL Prescription AB No No
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 20MG TABLET;ORAL Prescription AB No No
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 40MG 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
11/25/2003 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
09/29/2009 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

05/08/2007 SUPPL-3 Labeling

Label is not available on this site.

FOSINOPRIL SODIUM

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 10MG TABLET;ORAL Prescription No AB 076906 APOTEX INC
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 10MG TABLET;ORAL Prescription No AB 091163 AUROBINDO PHARMA LTD
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 10MG TABLET;ORAL Prescription No AB 077222 INVAGEN PHARMS
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 10MG TABLET;ORAL Prescription No AB 205670 PRINSTON INC
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 10MG TABLET;ORAL Prescription No AB 076139 TEVA
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 10MG TABLET;ORAL Prescription No AB 076483 UPSHER SMITH LABS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 20MG TABLET;ORAL Prescription No AB 076906 APOTEX INC
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 20MG TABLET;ORAL Prescription No AB 091163 AUROBINDO PHARMA LTD
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 20MG TABLET;ORAL Prescription No AB 077222 INVAGEN PHARMS
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 20MG TABLET;ORAL Prescription No AB 205670 PRINSTON INC
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 20MG TABLET;ORAL Prescription No AB 076139 TEVA
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 20MG TABLET;ORAL Prescription No AB 076483 UPSHER SMITH LABS

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 40MG TABLET;ORAL Prescription No AB 076906 APOTEX INC
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 40MG TABLET;ORAL Prescription No AB 091163 AUROBINDO PHARMA LTD
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 40MG TABLET;ORAL Prescription No AB 077222 INVAGEN PHARMS
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 40MG TABLET;ORAL Prescription No AB 205670 PRINSTON INC
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 40MG TABLET;ORAL Prescription No AB 076139 TEVA
FOSINOPRIL SODIUM FOSINOPRIL SODIUM 40MG TABLET;ORAL Prescription No AB 076483 UPSHER SMITH LABS

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