Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 015197
Company: CLOVER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMICAR AMINOCAPROIC ACID 500MG TABLET;ORAL Prescription AB Yes No
AMICAR AMINOCAPROIC ACID 1GM TABLET;ORAL Prescription None Yes 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
06/03/1964 ORIG-1 Approval Type 1 - New Molecular Entity 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
08/19/2008 SUPPL-43 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015230s035, 015197s043ltr.pdf
08/24/2004 SUPPL-40 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197s040,15229s031,15230s031ltr.pdf
06/24/2004 SUPPL-39 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf
06/24/2004 SUPPL-38 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf
06/24/2004 SUPPL-37 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf
06/24/2004 SUPPL-36 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf
11/27/2000 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

04/03/2000 SUPPL-34 Labeling

Label is not available on this site.

10/02/2000 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1999 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1997 SUPPL-30 Labeling

Label is not available on this site.

02/11/1992 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/13/1992 SUPPL-28 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/17/1986 SUPPL-27 Labeling

Label is not available on this site.

06/06/1983 SUPPL-26 Labeling

Label is not available on this site.

12/10/1982 SUPPL-25 Labeling

Label is not available on this site.

09/22/1982 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/03/1990 SUPPL-23 Labeling

Label is not available on this site.

10/22/1982 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1981 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/09/1977 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/19/2008 SUPPL-43 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf
06/24/2004 SUPPL-39 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf
06/24/2004 SUPPL-38 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf
06/24/2004 SUPPL-37 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf
06/24/2004 SUPPL-36 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf

AMICAR

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMICAR AMINOCAPROIC ACID 500MG TABLET;ORAL Prescription Yes AB 015197 CLOVER PHARMS
AMINOCAPROIC AMINOCAPROIC ACID 500MG TABLET;ORAL Prescription No AB 075602 AKORN

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