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Last Updated: April 16, 2024

Details for New Drug Application (NDA): 209353

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NDA 209353 describes ALTRENO, which is a drug marketed by Dow Pharm and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ALTRENO profile page.

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

Summary for 209353

Tradename:	ALTRENO
Applicant:	Dow Pharm
Ingredient:	tretinoin
Patents:	2
Formulation / Manufacturing:	see details

Pharmacology for NDA: 209353

Medical Subject Heading (MeSH) Categories for 209353

Antineoplastic Agents
Keratolytic Agents

Suppliers and Packaging for NDA: 209353

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALTRENO	tretinoin	LOTION;TOPICAL	209353	NDA	Bausch Health US, LLC	0187-0005	0187-0005-03	6 TUBE in 1 CARTON (0187-0005-03) / 3 g in 1 TUBE
ALTRENO	tretinoin	LOTION;TOPICAL	209353	NDA	Bausch Health US, LLC	0187-0005	0187-0005-10	10 TUBE in 1 CARTON (0187-0005-10) / 3 g in 1 TUBE (0187-0005-04)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LOTION;TOPICAL			Strength	0.05%
Approval Date:	Aug 23, 2018	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Aug 22, 2038	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER
Patent:	⤷ Try a Trial	Patent Expiration:	Aug 22, 2038	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER

Expired US Patents for NDA 209353

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353-001	Aug 23, 2018	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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