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Generated: November 20, 2018

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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. 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-four 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:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209353
Ingredient-typeRetinoids
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 Valeant Pharmaceuticals North America 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 Valeant Pharmaceuticals North America LLC 0187-0005 0187-0005-45 1 TUBE in 1 CARTON (0187-0005-45) > 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.05%
Approval Date:Aug 23, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 23, 2021
Regulatory Exclusivity Use:NEW DOSAGE FORM

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