Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208754
Company: P AND L

Products on ANDA 208754

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOCOSANOL	DOCOSANOL	10%	CREAM;TOPICAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208754

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/19/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208754Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/28/2023	SUPPL-7	Labeling-Container/Carton Labels		Label is not available on this site.

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

DOCOSANOL

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 PHARMS