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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215374
Company: ZENARA

Products on ANDA 215374

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMINOCAPROIC ACID	AMINOCAPROIC ACID	250MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215374

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/28/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215374

AMINOCAPROIC ACID

INJECTABLE;INJECTION; 250MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMINOCAPROIC ACID	AMINOCAPROIC ACID	250MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	071192	LUITPOLD
AMINOCAPROIC ACID	AMINOCAPROIC ACID	250MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215374	ZENARA
AMINOCAPROIC ACID IN PLASTIC CONTAINER	AMINOCAPROIC ACID	250MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	070010	HOSPIRA

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