Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020802
Company: GLAXOSMITHKLINE CONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EXCEDRIN (MIGRAINE) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250MG;250MG;65MG TABLET;ORAL Over-the-counter None 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
01/14/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020802_s000_ExcedrinTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/27/2020 SUPPL-34 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020802Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020802Orig1s034ltr.pdf
04/15/2019 SUPPL-33 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020802Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020802Orig1s033ltr.pdf
01/02/2018 SUPPL-32 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020802s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020802s032ltr.pdf
10/12/2017 SUPPL-31 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020802s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020802Orig1s031ltr.pdf
09/13/2017 SUPPL-30

Label is not available on this site.

04/29/2016 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

01/28/2016 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

11/17/2015 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/30/2014 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/15/2014 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020802Orig1s024ltr.pdf
04/15/2014 SUPPL-22 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802s022.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020802Orig1s022ltr.pdf
02/04/2010 SUPPL-19 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020802s019ltr.pdf
01/31/2007 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020802s015ltr.pdf
08/27/2004 SUPPL-10 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20802s010ltr.pdf
05/21/2003 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20802slr009_excedrin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20802slr009ltr.pdf
04/19/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/10/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/26/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/2000 SUPPL-4 Labeling

Label is not available on this site.

08/20/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/07/1999 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20802s02lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20802s02ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-802s002_Excedrin.cfm
10/22/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/27/2020 SUPPL-34 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020802Orig1s034lbl.pdf
04/15/2019 SUPPL-33 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020802Orig1s033lbl.pdf
01/02/2018 SUPPL-32 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020802s033lbl.pdf
10/12/2017 SUPPL-31 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020802s031lbl.pdf
07/15/2014 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802Orig1s024lbl.pdf
04/15/2014 SUPPL-22 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802s022.pdf
05/21/2003 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20802slr009_excedrin_lbl.pdf
10/07/1999 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20802s02lbl.pdf

EXCEDRIN (MIGRAINE)

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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