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Serving leading biopharmaceutical companies globally:

McKesson
Argus Health
Citi
Merck
Farmers Insurance
Healthtrust
Harvard Business School
US Department of Justice
Cipla
Cantor Fitzgerald

Generated: December 11, 2017

DrugPatentWatch Database Preview

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-four drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

Summary for 020404

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

Pharmacology for NDA: 020404

Ingredient-typeRetinoids

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 0378-6141-45 45 g in 1 TUBE (0378-6141-45)
AVITA tretinoin CREAM;TOPICAL 020404 NDA Mylan Pharmaceuticals Inc. 0378-6141 0378-6141-44 20 g in 1 TUBE (0378-6141-44)

Summary for product number 003

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

Expired Orange Book Patents for NDA: 020404

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Pharms IncAVITAtretinoinCREAM;TOPICAL020404-003Jan 14, 1997► Subscribe► Subscribe
Mylan Pharms IncAVITAtretinoinCREAM;TOPICAL020404-003Jan 14, 1997► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Baxter
Cantor Fitzgerald
UBS
Cipla
US Department of Justice
Colorcon
Moodys
Julphar
US Army
Accenture

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