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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Moodys
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Healthtrust
US Army
Dow
QuintilesIMS
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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075137

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NDA 075137 describes OXYBUTYNIN CHLORIDE, which is a drug marketed by Apotex Inc, Mikart, Pharm Assoc, Silarx, Vintage Pharms, Wockhardt, Accord Hlthcare, Amneal Pharms, Impax Pharms, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Unique Pharm Labs, Zydus Pharms Usa Inc, Novitium Pharma, Quantum Pharmics, Teva Pharms Usa, Upsher-smith Labs, Usl Pharma, and Watson Labs, and is included in twenty-one NDAs. It is available from forty-nine 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-three suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.

Summary for 075137

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

Pharmacology for NDA: 075137

Suppliers and Packaging for NDA: 075137

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYBUTYNIN CHLORIDE oxybutynin chloride SYRUP;ORAL 075137 ANDA Pharmaceutical Associates, Inc. 0121-0671 0121-0671-16 473 mL in 1 BOTTLE (0121-0671-16)
OXYBUTYNIN CHLORIDE oxybutynin chloride SYRUP;ORAL 075137 ANDA Pharmaceutical Associates, Inc. 0121-0671 0121-0671-05 4 TRAY in 1 CASE (0121-0671-05) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Dec 18, 1998TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Covington
Medtronic
AstraZeneca
Daiichi Sankyo
Teva
Federal Trade Commission
Baxter
Cerilliant
Healthtrust
Farmers Insurance

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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