BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Farmers Insurance
Express Scripts
US Department of Justice
Cantor Fitzgerald

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050803

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NDA 050803 describes VELTIN, which is a drug marketed by Aqua Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the VELTIN profile page.

The generic ingredient in VELTIN is clindamycin phosphate; tretinoin. There are fifty-four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.
Summary for 050803
Applicant:Aqua Pharms Llc
Ingredient:clindamycin phosphate; tretinoin
Formulation / Manufacturing:see details
Pharmacology for NDA: 050803
Suppliers and Packaging for NDA: 050803
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VELTIN clindamycin phosphate; tretinoin GEL;TOPICAL 050803 NDA Aqua Pharmaceuticals 16110-071 16110-071-30 1 TUBE in 1 CARTON (16110-071-30) > 30 g in 1 TUBE
VELTIN clindamycin phosphate; tretinoin GEL;TOPICAL 050803 NDA Aqua Pharmaceuticals 16110-071 16110-071-60 1 TUBE in 1 CARTON (16110-071-60) > 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength1.2%;0.025%
Approval Date:Jul 16, 2010TE:BXRLD:Yes

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Boehringer Ingelheim

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