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ABREVA از شرکت GLAXOSMITHKLINE

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ABREVA از شرکت GLAXOSMITHKLINE

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-Package Insert, Labeling-Container/Carton Labels

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-Package Insert, Labeling-Container/Carton Labels

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-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020941s006lbl.pdf
05/23/2007 SUPPL-6

Labeling-Container/Carton Labels

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
DOCOSANOL DOCOSANOL 10% CREAM;TOPICAL Over-the-counter No 208754 P AND L
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بخوانید  ABREVA از شرکت GLAXOSMITHKLINE
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