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Generated: January 22, 2019

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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 two suppliers. 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. Thirty-eight suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
Summary for 050801
Tradename:EVOCLIN
Applicant:Mylan Pharms Inc
Ingredient:clindamycin phosphate
Patents:2
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength1%
Approval Date:Oct 22, 2004TE:ATRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jan 23, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Aug 9, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ACNE VULGARIS

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