Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212894
Company: AMNEAL

Products on ANDA 212894

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENALAPRIL MALEATE	ENALAPRIL MALEATE	1MG/ML	SOLUTION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212894

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212894

ENALAPRIL MALEATE

SOLUTION;ORAL; 1MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ENALAPRIL MALEATE	ENALAPRIL MALEATE	1MG/ML	SOLUTION;ORAL	Prescription	No	AB	213714	ALKEM LABS LTD
ENALAPRIL MALEATE	ENALAPRIL MALEATE	1MG/ML	SOLUTION;ORAL	Prescription	No	AB	212894	AMNEAL
ENALAPRIL MALEATE	ENALAPRIL MALEATE	1MG/ML	SOLUTION;ORAL	Prescription	No	AB	214467	ANNORA PHARMA
ENALAPRIL MALEATE	ENALAPRIL MALEATE	1MG/ML	SOLUTION;ORAL	Prescription	No	AB	216458	AUROBINDO PHARMA
ENALAPRIL MALEATE	ENALAPRIL MALEATE	1MG/ML	SOLUTION;ORAL	Prescription	No	AB	212408	BIONPHARMA
EPANED	ENALAPRIL MALEATE	1MG/ML	SOLUTION;ORAL	Prescription	Yes	AB	208686	AZURITY