Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 015230
Company: CLOVER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMICAR AMINOCAPROIC ACID 1.25GM/5ML SYRUP;ORAL Prescription AA 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
06/04/1964 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
02/03/2009 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015230s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/015230s037ltr.pdf
08/19/2008 SUPPL-35 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-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197s040,15229s031,15230s031ltr.pdf
09/02/2003 SUPPL-30 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp030ltr.pdf
09/02/2003 SUPPL-29 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp030ltr.pdf
09/02/2003 SUPPL-28 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp030ltr.pdf
09/14/1999 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1999 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/14/1999 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/17/1997 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1997 SUPPL-23 Labeling

Label is not available on this site.

11/04/1986 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/17/1986 SUPPL-21 Labeling

Label is not available on this site.

06/06/1983 SUPPL-20 Labeling

Label is not available on this site.

12/10/1982 SUPPL-19 Labeling

Label is not available on this site.

09/22/1982 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/03/1990 SUPPL-17 Labeling

Label is not available on this site.

12/22/1980 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/17/1978 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/03/2009 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015230s037lbl.pdf
08/19/2008 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf

AMICAR

SYRUP;ORAL; 1.25GM/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMICAR AMINOCAPROIC ACID 1.25GM/5ML SYRUP;ORAL Prescription Yes AA 015230 CLOVER PHARMS
AMINOCAPROIC ACID AMINOCAPROIC ACID 1.25GM/5ML SYRUP;ORAL Prescription No AA 074759 AKORN

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