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Last Updated: July 10, 2020

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 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-five drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
Summary for 050801
Ingredient:clindamycin phosphate
Formulation / Manufacturing:see details
Pharmacology for NDA: 050801
Suppliers and Packaging for NDA: 050801
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EVOCLIN clindamycin phosphate AEROSOL, FOAM;TOPICAL 050801 NDA Mylan Pharmaceuticals Inc. 0378-8134 0378-8134-01 1 CAN in 1 CARTON (0378-8134-01) > 100 g in 1 CAN
EVOCLIN clindamycin phosphate AEROSOL, FOAM;TOPICAL 050801 NDA Mylan Pharmaceuticals Inc. 0378-8134 0378-8134-50 1 CAN in 1 CARTON (0378-8134-50) > 50 g in 1 CAN
Paragraph IV (Patent) Challenges for 050801
Tradename Dosage Ingredient NDA Submissiondate
EVOCLIN AEROSOL, FOAM;TOPICAL clindamycin phosphate 050801

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength1%
Approval Date:Oct 22, 2004TE:ATRLD:Yes
Patent:  Start TrialPatent Expiration:Feb 3, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jan 23, 2024Product Flag?YSubstance Flag?Delist Request?

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