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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 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-four suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

Summary for NDA: 020404

Mylan Pharms Inc
Therapeutic Class:Antineoplastics
Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020404


Suppliers and Packaging for NDA: 020404

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CREAM;TOPICAL 020404 NDA Mylan Pharmaceuticals Inc. 0378-6141 0378-6141-44 20 g in 1 TUBE (0378-6141-44)
CREAM;TOPICAL 020404 NDA Mylan Pharmaceuticals Inc. 0378-6141 0378-6141-45 45 g in 1 TUBE (0378-6141-45)

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 Inc
CREAM;TOPICAL020404-003Jan 14, 19974,971,800► subscribe
Mylan Pharms Inc
CREAM;TOPICAL020404-003Jan 14, 19975,045,317► subscribe
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