Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018590
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOCAPROIC ACID AMINOCAPROIC ACID 250MG/ML INJECTABLE;INJECTION Discontinued None 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
10/29/1982 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
09/09/1999 SUPPL-17 Labeling

Label is not available on this site.

10/22/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/16/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/19/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/06/1992 SUPPL-13 Labeling

Label is not available on this site.

11/03/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/25/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

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