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Details for New Drug Application (NDA): 074868

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NDA 074868 describes OXYBUTYNIN CHLORIDE, which is a drug marketed by Mylan, Osmotica Pharm Us, Amneal Pharms, Silarx, Unique Pharm Labs, Usl Pharma, 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 nineteen NDAs. It is available from forty-two 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. Forty-five suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.

Summary for NDA: 074868

oxybutynin chloride
Therapeutic Class:Genitourinary Agents

Pharmacology for NDA: 074868

Suppliers and Packaging for NDA: 074868

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
oxybutynin chloride
SYRUP;ORAL 074868 ANDA Morton Grove Pharmaceuticals, Inc. 60432-092 60432-092-16 473 mL in 1 BOTTLE (60432-092-16)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Feb 12, 1997TE:AARLD:Yes

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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.