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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
US Army
Daiichi Sankyo
Express Scripts
Argus Health

Generated: September 23, 2017

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-two 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 NDA: 050803

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
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
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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 050803

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Aqua Pharms Llc
clindamycin phosphate; tretinoin
GEL;TOPICAL050803-001Jul 16, 2010► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Queensland Health
Express Scripts
Johnson and Johnson
Argus Health
Chinese Patent Office

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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