Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075479
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ENALAPRIL MALEATE ENALAPRIL MALEATE 2.5MG TABLET;ORAL Prescription AB No No
ENALAPRIL MALEATE ENALAPRIL MALEATE 5MG TABLET;ORAL Prescription AB No No
ENALAPRIL MALEATE ENALAPRIL MALEATE 10MG TABLET;ORAL Prescription AB No No
ENALAPRIL MALEATE ENALAPRIL MALEATE 20MG 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
08/22/2000 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75479ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75479ta.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/05/2021 SUPPL-42 Labeling-Package Insert

Label is not available on this site.

08/05/2021 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

08/05/2021 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

08/05/2021 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

12/31/2008 SUPPL-30 Labeling

Label is not available on this site.

04/23/2008 SUPPL-28 Labeling

Label is not available on this site.

08/13/2002 SUPPL-4 Labeling

Label is not available on this site.

03/19/2002 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/30/2001 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

ENALAPRIL MALEATE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ENALAPRIL MALEATE ENALAPRIL MALEATE 2.5MG TABLET;ORAL Prescription No AB 075479 HERITAGE PHARMA
ENALAPRIL MALEATE ENALAPRIL MALEATE 2.5MG TABLET;ORAL Prescription No AB 075496 SANDOZ INC
ENALAPRIL MALEATE ENALAPRIL MALEATE 2.5MG TABLET;ORAL Prescription No AB 075657 TARO
ENALAPRIL MALEATE ENALAPRIL MALEATE 2.5MG TABLET;ORAL Prescription No AB 075483 WOCKHARDT LTD
VASOTEC ENALAPRIL MALEATE 2.5MG TABLET;ORAL Prescription Yes AB 018998 BAUSCH

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ENALAPRIL MALEATE ENALAPRIL MALEATE 5MG TABLET;ORAL Prescription No AB 075479 HERITAGE PHARMA
ENALAPRIL MALEATE ENALAPRIL MALEATE 5MG TABLET;ORAL Prescription No AB 075496 SANDOZ INC
ENALAPRIL MALEATE ENALAPRIL MALEATE 5MG TABLET;ORAL Prescription No AB 075657 TARO
ENALAPRIL MALEATE ENALAPRIL MALEATE 5MG TABLET;ORAL Prescription No AB 075483 WOCKHARDT LTD
VASOTEC ENALAPRIL MALEATE 5MG TABLET;ORAL Prescription Yes AB 018998 BAUSCH

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ENALAPRIL MALEATE ENALAPRIL MALEATE 10MG TABLET;ORAL Prescription No AB 075479 HERITAGE PHARMA
ENALAPRIL MALEATE ENALAPRIL MALEATE 10MG TABLET;ORAL Prescription No AB 075459 SANDOZ INC
ENALAPRIL MALEATE ENALAPRIL MALEATE 10MG TABLET;ORAL Prescription No AB 075657 TARO
ENALAPRIL MALEATE ENALAPRIL MALEATE 10MG TABLET;ORAL Prescription No AB 075483 WOCKHARDT LTD
VASOTEC ENALAPRIL MALEATE 10MG TABLET;ORAL Prescription Yes AB 018998 BAUSCH

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ENALAPRIL MALEATE ENALAPRIL MALEATE 20MG TABLET;ORAL Prescription No AB 075479 HERITAGE PHARMA
ENALAPRIL MALEATE ENALAPRIL MALEATE 20MG TABLET;ORAL Prescription No AB 075459 SANDOZ INC
ENALAPRIL MALEATE ENALAPRIL MALEATE 20MG TABLET;ORAL Prescription No AB 075657 TARO
ENALAPRIL MALEATE ENALAPRIL MALEATE 20MG TABLET;ORAL Prescription No AB 075483 WOCKHARDT LTD
VASOTEC ENALAPRIL MALEATE 20MG TABLET;ORAL Prescription Yes AB 018998 BAUSCH

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