Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074759
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOCAPROIC ACID AMINOCAPROIC ACID 1.25GM/5ML SYRUP;ORAL Prescription AA 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
09/02/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74759_Aminocaproic%20Acid.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74759ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074759_Aminocaproic_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2010 SUPPL-11 Labeling

Label is not available on this site.

08/31/2010 SUPPL-10 Labeling

Label is not available on this site.

08/13/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

04/23/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/2002 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/02/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74759_Aminocaproic%20Acid.pdf

AMINOCAPROIC ACID

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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