Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 015229
Company: CLOVER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMICAR AMINOCAPROIC ACID 250MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
06/08/1964 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/24/2004 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197s040,15229s031,15230s031ltr.pdf
04/03/2000 SUPPL-30 Labeling

Label is not available on this site.

10/01/1999 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1997 SUPPL-28 Labeling

Label is not available on this site.

03/07/1995 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1994 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1995 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/17/1986 SUPPL-24 Labeling

Label is not available on this site.

12/05/1983 SUPPL-22 Efficacy

Label is not available on this site.

06/06/1983 SUPPL-21 Labeling

Label is not available on this site.

12/10/1982 SUPPL-20 Labeling

Label is not available on this site.

09/22/1982 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/03/1990 SUPPL-18 Labeling

Label is not available on this site.

09/07/1979 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/10/1979 SUPPL-15 Labeling

Label is not available on this site.

12/14/1977 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/14/1977 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1977 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/10/1977 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

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