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Generated: May 29, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050801

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NDA 050801 describes EVOCLIN, which is a drug marketed by Mylan Pharms Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EVOCLIN profile page.

The generic ingredient in EVOCLIN is clindamycin phosphate. There are fifty-two drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

Summary for NDA: 050801

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050801

Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 050801

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
clindamycin phosphate
AEROSOL, FOAM;TOPICAL 050801 NDA Prestium Pharma, Inc. 40076-061 40076-061-00 1 CAN in 1 CARTON (40076-061-00) > 100 g in 1 CAN
clindamycin phosphate
AEROSOL, FOAM;TOPICAL 050801 NDA Prestium Pharma, Inc. 40076-061 40076-061-50 1 CAN in 1 CARTON (40076-061-50) > 50 g in 1 CAN

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength1%
Approval Date:Oct 22, 2004TE:ATRLD:Yes
Patent:7,141,237Patent Expiration:Jan 23, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:7,374,747Patent Expiration:Aug 9, 2026Product Flag?YSubstance Flag?YDelist Request?

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