Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075472
Company: MYLAN

Products on ANDA 075472

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET;ORAL	Discontinued	None	No	No
ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET;ORAL	Discontinued	None	No	No
ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET;ORAL	Discontinued	None	No	No
ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075472

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/2000/75472ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75472ta.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/22/2002	SUPPL-2	Labeling		Label is not available on this site.