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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020941
Company: HALEON US HOLDINGS

Products on NDA 020941

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020941

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.

Labels for NDA 020941

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

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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	HALEON US HOLDINGS
DOCOSANOL	DOCOSANOL	10%	CREAM;TOPICAL	Over-the-counter	No	215839	ALEMBIC
DOCOSANOL	DOCOSANOL	10%	CREAM;TOPICAL	Over-the-counter	No	217090	AUROBINDO PHARMA LTD
DOCOSANOL	DOCOSANOL	10%	CREAM;TOPICAL	Over-the-counter	No	208754	P AND L
DOCOSANOL	DOCOSANOL	10%	CREAM;TOPICAL	Over-the-counter	No	212385	P AND L DEVELOPMENT
DOCOSANOL	DOCOSANOL	10%	CREAM;TOPICAL	Over-the-counter	No	214454	TARO

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