Drugs@FDA: FDA Approved Drug Products

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

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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