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Last Updated: September 26, 2022

Details for New Drug Application (NDA): 020400

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NDA 020400 describes AVITA, which is a drug marketed by Mylan Pharms Inc and Mylan and is included in two NDAs. It is available from four suppliers. Additional details are available on the AVITA profile page.

The generic ingredient in AVITA is tretinoin. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
Summary for 020400
Formulation / Manufacturing:see details
Pharmacology for NDA: 020400
Medical Subject Heading (MeSH) Categories for 020400
Suppliers and Packaging for NDA: 020400
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AVITA tretinoin GEL;TOPICAL 020400 NDA Mylan Pharmaceuticals Inc. 0378-6140 0378-6140-44 20 g in 1 TUBE (0378-6140-44)
AVITA tretinoin GEL;TOPICAL 020400 NDA Mylan Pharmaceuticals Inc. 0378-6140 0378-6140-45 45 g in 1 TUBE (0378-6140-45)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.025%
Approval Date:Jan 29, 1998TE:BTRLD:No

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