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Generated: April 20, 2019

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Details for New Drug Application (NDA): 050782

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NDA 050782 describes CLINDAGEL, which is a drug marketed by Precision Dermat and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the CLINDAGEL profile page.

The generic ingredient in CLINDAGEL is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
Summary for 050782
Applicant:Precision Dermat
Ingredient:clindamycin phosphate
Formulation / Manufacturing:see details
Pharmacology for NDA: 050782
Suppliers and Packaging for NDA: 050782
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAGEL clindamycin phosphate GEL;TOPICAL 050782 NDA Onset Dermatologics LLC 16781-462 16781-462-06 6 BOTTLE in 1 CARTON (16781-462-06) > 7.3 mL in 1 BOTTLE
CLINDAGEL clindamycin phosphate GEL;TOPICAL 050782 NDA Onset Dermatologics LLC 16781-462 16781-462-75 1 BOTTLE in 1 CARTON (16781-462-75) > 75 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrengthEQ 1% BASE
Approval Date:Nov 27, 2000TE:BTRLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 3, 2020Product Flag?YSubstance Flag?Delist Request?

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