Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075794
Company: PERRIGO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN, ASPIRIN AND CAFFEINE ACETAMINOPHEN; ASPIRIN; CAFFEINE 250MG;250MG;65MG TABLET;ORAL Over-the-counter None 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
11/26/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75794apdF.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/26/2016 SUPPL-45 Labeling-Container/Carton Labels

Label is not available on this site.

12/12/2014 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

11/22/2010 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

03/05/2008 SUPPL-26 Labeling

Label is not available on this site.

11/21/2006 SUPPL-22 Labeling

Label is not available on this site.

12/17/2003 SUPPL-12 Labeling

Label is not available on this site.

10/08/2003 SUPPL-8 Labeling

Label is not available on this site.

08/16/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/16/2002 SUPPL-3 Labeling

Label is not available on this site.

08/16/2002 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/16/2002 SUPPL-1 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 250MG;250MG;65MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ACETAMINOPHEN, ASPIRIN AND CAFFEINE ACETAMINOPHEN; ASPIRIN; CAFFEINE 250MG;250MG;65MG TABLET;ORAL Over-the-counter No 075794 PERRIGO
EXCEDRIN (MIGRAINE) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250MG;250MG;65MG TABLET;ORAL Over-the-counter Yes 020802 GLAXOSMITHKLINE CONS

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