You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

Details for New Drug Application (NDA): 201000

✉ Email this page to a colleague

« Back to Dashboard

NDA 201000 describes ADAPALENE, which is a drug marketed by Fougera Pharms, Actavis Mid Atlantic, Alembic, Encube Ethicals, Glenmark Pharms Inc, P And L, Taro, Call Inc, Actavis Labs Ut Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, and Zydus Pharms, and is included in twenty NDAs. It is available from thirty-six suppliers. Additional details are available on the ADAPALENE profile page.

The generic ingredient in ADAPALENE is adapalene; benzoyl peroxide. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.

Summary for 201000

Tradename:	ADAPALENE
Applicant:	Actavis Mid Atlantic
Ingredient:	adapalene
Patents:	0

Pharmacology for NDA: 201000

Medical Subject Heading (MeSH) Categories for 201000

Anti-Inflammatory Agents, Non-Steroidal
Dermatologic Agents

Suppliers and Packaging for NDA: 201000

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADAPALENE	adapalene	GEL;TOPICAL	201000	ANDA	Actavis Pharma, Inc.	0472-0126	0472-0126-45	1 TUBE in 1 CARTON (0472-0126-45) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.3%
Approval Date:	Oct 27, 2014	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.