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Last Updated: November 22, 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-six 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
Pharmacology for NDA: 209353
Medical Subject Heading (MeSH) Categories for 209353
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:RXDosage:LOTION;TOPICALStrength0.05%
Approval Date:Aug 23, 2018TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Aug 22, 2038Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER
Patent:⤷  Sign UpPatent Expiration:Aug 22, 2038Product 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

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

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