Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209060
Company: SUNNY

Products on ANDA 209060

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMINOCAPROIC ACID	AMINOCAPROIC ACID	500MG	TABLET;ORAL	Prescription	AB	No	No
AMINOCAPROIC ACID	AMINOCAPROIC ACID	1GM	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209060

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209060Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 209060

AMINOCAPROIC ACID

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMINOCAPROIC ACID	AMINOCAPROIC ACID	500MG	TABLET;ORAL	Prescription	No	AB	212492	AMNEAL
AMINOCAPROIC ACID	AMINOCAPROIC ACID	500MG	TABLET;ORAL	Prescription	No	AB	211629	ANI PHARMS
AMINOCAPROIC ACID	AMINOCAPROIC ACID	500MG	TABLET;ORAL	Prescription	No	AB	213928	CARNEGIE
AMINOCAPROIC ACID	AMINOCAPROIC ACID	500MG	TABLET;ORAL	Prescription	No	AB	212938	MSN
AMINOCAPROIC ACID	AMINOCAPROIC ACID	500MG	TABLET;ORAL	Prescription	No	AB	213944	OPTIMUS
AMINOCAPROIC ACID	AMINOCAPROIC ACID	500MG	TABLET;ORAL	Prescription	No	AB	209060	SUNNY

TABLET;ORAL; 1GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMINOCAPROIC ACID	AMINOCAPROIC ACID	1GM	TABLET;ORAL	Prescription	No	AB	213928	CARNEGIE
AMINOCAPROIC ACID	AMINOCAPROIC ACID	1GM	TABLET;ORAL	Prescription	No	AB	212938	MSN
AMINOCAPROIC ACID	AMINOCAPROIC ACID	1GM	TABLET;ORAL	Prescription	No	AB	213944	OPTIMUS
AMINOCAPROIC ACID	AMINOCAPROIC ACID	1GM	TABLET;ORAL	Prescription	No	AB	209060	SUNNY