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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 Delcor Asset Corp 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-one suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

Summary for NDA: 050801

Tradename:
EVOCLIN
Applicant:
Delcor Asset Corp
Ingredient:
clindamycin phosphate
Patents:2
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050801

Ingredient-typeLincosamides
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
EVOCLIN
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
EVOCLIN
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?
Patented Use:TREATMENT OF ACNE VULGARIS


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