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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Deloitte
Express Scripts
Federal Trade Commission
QuintilesIMS
Covington
Medtronic
Queensland Health
Chinese Patent Office
Johnson and Johnson
Healthtrust

Generated: December 16, 2017

DrugPatentWatch Database Preview

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 one supplier. 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-three 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 050782

Tradename:1
Applicant:1
Ingredient:1
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050782

Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrengthEQ 1% BASE
Approval Date:Nov 27, 2000TE:BTRLD:Yes
Patent:► SubscribePatent Expiration:Aug 3, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF ACNE VULGARIS


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Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Boehringer Ingelheim
Johnson and Johnson
Federal Trade Commission
Merck
Cantor Fitzgerald
Harvard Business School
Deloitte
US Army

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