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Generated: April 24, 2019

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Details for New Drug Application (NDA): 020404

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NDA 020404 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. Twenty-four suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
Summary for 020404
Applicant:Mylan Pharms Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 020404
Medical Subject Heading (MeSH) Categories for 020404
Suppliers and Packaging for NDA: 020404
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AVITA tretinoin CREAM;TOPICAL 020404 NDA Mylan Pharmaceuticals Inc. 0378-6141 0378-6141-44 20 g in 1 TUBE (0378-6141-44)
AVITA tretinoin CREAM;TOPICAL 020404 NDA Mylan Pharmaceuticals Inc. 0378-6141 0378-6141-45 45 g in 1 TUBE (0378-6141-45)

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.025%
Approval Date:Jan 14, 1997TE:ABRLD:No

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