You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 25, 2026

Details for New Drug Application (NDA): 215713

✉ Email this page to a colleague

« Back to Dashboard

NDA 215713 describes TRETINOIN, which is a drug marketed by Barr Labs Inc, Glenmark Pharms Ltd, Ph Health, Alembic, Allergan, Encube, Padagis Us, Sun Pharma Canada, Zo Skin Health, Zydus Lifesciences, Aurobindo Pharma Ltd, Mylan, Rising, Teva Pharms, and Wockhardt, and is included in twenty-nine NDAs. It is available from twenty suppliers. Additional details are available on the TRETINOIN profile page.

The generic ingredient in TRETINOIN is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

Summary for 215713

Tradename:	TRETINOIN
Applicant:	Sun Pharma Canada
Ingredient:	tretinoin
Patents:	0

Pharmacology for NDA: 215713

Medical Subject Heading (MeSH) Categories for 215713

Antineoplastic Agents
Keratolytic Agents

Suppliers and Packaging for NDA: 215713

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRETINOIN	tretinoin	CREAM;TOPICAL	215713	ANDA	NORTHSTAR RX LLC	16714-270	16714-270-01	1 TUBE in 1 CARTON (16714-270-01) / 20 g in 1 TUBE
TRETINOIN	tretinoin	CREAM;TOPICAL	215713	ANDA	NORTHSTAR RX LLC	16714-270	16714-270-02	1 TUBE in 1 CARTON (16714-270-02) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.025%
Approval Date:	Jan 5, 2023	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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.