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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-four 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 NDA: 022070

Tradename:
ATRALIN
Applicant:
Dow Pharm
Ingredient:
tretinoin
Patents:0
Therapeutic Class:Antineoplastics
Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022070

Ingredient-typeRetinoids

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 Coria Laboratories 13548-070 13548-070-01 2 g in 1 TUBE (13548-070-01)
ATRALIN
tretinoin
GEL;TOPICAL 022070 NDA Coria Laboratories 13548-070 13548-070-45 1 TUBE in 1 PACKAGE (13548-070-45) > 45 g in 1 TUBE

Summary for product number 001

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

Expired Orange Book Patents for NDA: 022070

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Dow Pharm
ATRALIN
tretinoin
GEL;TOPICAL022070-001Jul 26, 20075,670,547► subscribe
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