Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020941
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABREVA DOCOSANOL 10% CREAM;TOPICAL 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
07/25/2000 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20941lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20941ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-941_Abreva.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/10/2017 SUPPL-12 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020941Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020941Orig1s012ltr.pdf
01/30/2015 SUPPL-11 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020941Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020941Orig1s011ltr.pdf
02/08/2008 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020941s009ltr.pdf
05/23/2007 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020941s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020941s006ltr.pdf
12/13/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/2001 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/12/2001 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
01/10/2017 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020941Orig1s012lbl.pdf
01/30/2015 SUPPL-11 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020941Orig1s011lbl.pdf
05/23/2007 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020941s006lbl.pdf
05/23/2007 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020941s006lbl.pdf
07/25/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20941lbl.pdf

ABREVA

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

CREAM;TOPICAL; 10%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ABREVA DOCOSANOL 10% CREAM;TOPICAL Over-the-counter Yes 020941 GLAXOSMITHKLINE

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