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BioPharmaceutical Business Intelligence

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Serving 500+ biopharmaceutical companies globally:

Moodys
Medtronic
Julphar
Cantor Fitzgerald
Fish and Richardson
Baxter
US Army
Citi
Federal Trade Commission
Express Scripts

Generated: September 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207138

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NDA 207138 describes OXYBUTYNIN CHLORIDE, which is a drug marketed by Mylan, Osmotica Pharm Us, Amneal Pharms, Silarx, Unique Pharm Labs, Usl Pharma, Zydus Pharms Usa Inc, Pharm Assoc, Accord Hlthcare, Mikart, Mylan Pharms Inc, Impax Pharms, Teva Pharms Usa, Wockhardt, Vintage Pharms, Watson Labs, Quantum Pharmics, and Apotex Inc, and is included in twenty NDAs. It is available from forty-seven suppliers. Additional details are available on the OXYBUTYNIN CHLORIDE profile page.

The generic ingredient in OXYBUTYNIN CHLORIDE is oxybutynin chloride. There are sixteen drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.

Summary for NDA: 207138

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 207138

Suppliers and Packaging for NDA: 207138

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL 207138 ANDA Accord Healthcare, Inc. 16729-317 16729-317-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-317-01)
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL 207138 ANDA Accord Healthcare, Inc. 16729-317 16729-317-16 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-317-16)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Feb 29, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Feb 29, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Feb 29, 2016TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
Chubb
Covington
Healthtrust
Moodys
Citi
Harvard Business School
Fuji
Cipla

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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