Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071192
Company: LUITPOLD

Products on ANDA 071192

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 071192

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/01/1987	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/26/2007	SUPPL-12	Labeling		Label is not available on this site.
02/04/2000	SUPPL-7	Labeling		Label is not available on this site.
10/19/1999	SUPPL-6	Labeling		Label is not available on this site.
08/28/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/28/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/28/1994	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/03/1991	SUPPL-2	Labeling		Label is not available on this site.
08/01/1991	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 071192

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 IN PLASTIC CONTAINER	AMINOCAPROIC ACID	250MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	070010	HOSPIRA