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Last Updated: January 17, 2021

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Details for New Drug Application (NDA): 022070

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NDA 022070 describes ATRALIN, which is a drug marketed by Dow Pharm and is included in one NDA. It is available from three suppliers. Additional details are available on the ATRALIN profile page.

The generic ingredient in ATRALIN is tretinoin. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
Summary for 022070
Applicant:Dow Pharm
Formulation / Manufacturing:see details
Pharmacology for NDA: 022070
Medical Subject Heading (MeSH) Categories for 022070
Suppliers and Packaging for NDA: 022070
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATRALIN tretinoin GEL;TOPICAL 022070 NDA Bausch Health US, LLC 13548-070 13548-070-45 1 TUBE in 1 PACKAGE (13548-070-45) > 45 g in 1 TUBE
ATRALIN tretinoin GEL;TOPICAL 022070 NDA AUTHORIZED GENERIC Obagi Cosmeceuticals LLC 62032-413 62032-413-20 20 g in 1 TUBE (62032-413-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.05%
Approval Date:Jul 26, 2007TE:ABRLD:Yes

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