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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070010
Company: HOSPIRA

Products on ANDA 070010

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070010

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/1987	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
02/27/2007	SUPPL-16	Labeling		Label is not available on this site.
11/15/2002	SUPPL-13	Labeling		Label is not available on this site.
02/15/2001	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/08/1999	SUPPL-11	Labeling		Label is not available on this site.
10/20/1999	SUPPL-10	Labeling		Label is not available on this site.
10/20/1999	SUPPL-9	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
09/08/1998	SUPPL-8	Labeling		Label is not available on this site.
10/03/1996	SUPPL-7	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/22/1996	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
01/26/1995	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/27/1994	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/21/1993	SUPPL-2	Labeling		Label is not available on this site.
12/03/1991	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 070010

AMINOCAPROIC ACID IN PLASTIC CONTAINER

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

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