Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075602
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOCAPROIC AMINOCAPROIC ACID 500MG TABLET;ORAL Prescription AB 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
05/24/2001 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75602ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075602_aminocaproic_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2010 SUPPL-10 Labeling

Label is not available on this site.

08/31/2010 SUPPL-9 Labeling

Label is not available on this site.

08/26/2004 SUPPL-4 Labeling

Label is not available on this site.

08/13/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

AMINOCAPROIC

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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