Drugs@FDA: FDA Approved Drug Products

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

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

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