Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 201000
Company: ACTAVIS MID ATLANTIC

Products on ANDA 201000

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADAPALENE	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201000

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/27/2014	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201000Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2024	SUPPL-7	Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/11/2023	SUPPL-6	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201000

ADAPALENE

GEL;TOPICAL; 0.3%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ADAPALENE	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	No	AB	201000	ACTAVIS MID ATLANTIC
ADAPALENE	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	No	AB	213508	ALEMBIC
ADAPALENE	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	No	AB	200298	ENCUBE ETHICALS
ADAPALENE	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	No	AB	208322	SUN PHARMA CANADA
DIFFERIN	ADAPALENE	0.3%	GEL;TOPICAL	Prescription	Yes	AB	021753	GALDERMA LABS LP