Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074759
Company: AKORN

Products on ANDA 074759

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074759

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.

Labels for ANDA 074759

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