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Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020400

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

The generic ingredient in AVITA is tretinoin. There are twenty-four drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

Summary for NDA: 020400

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antineoplastics
Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020400

Ingredient-typeRetinoids

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)

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Accenture
Medtronic
Colorcon
QuintilesIMS
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Cantor Fitzgerald
Healthtrust
Moodys
Teva

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