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Approved Drug Products containing Oxybutynin chloride [USAN:USP] listed in the FDA Orange Book. Original Data : FDA Website

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01

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OXYBUTYNIN CHLORIDE

Brand Name : GELNIQUE

Dosage Form : GEL;TRANSDERMAL

Dosage Strength : 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2009-01-27

Application Number : 22204

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code : AB

OXYBUTYNIN CHLORIDE

Brand Name : OXYBUTYNIN CHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 1997-10-31

Application Number : 75079

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code : AB

OXYBUTYNIN CHLORIDE

Brand Name : OXYBUTYNIN CHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2020-12-17

Application Number : 208165

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

04

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OXYBUTYNIN CHLORIDE

Brand Name : DITROPAN

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 17577

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

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OXYBUTYNIN CHLORIDE

Brand Name : DITROPAN XL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1998-12-16

Application Number : 20897

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

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OXYBUTYNIN CHLORIDE

Brand Name : DITROPAN XL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1998-12-16

Application Number : 20897

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

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OXYBUTYNIN CHLORIDE

Brand Name : DITROPAN XL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1999-06-22

Application Number : 20897

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

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OXYBUTYNIN CHLORIDE

Brand Name : DITROPAN

Dosage Form : SYRUP;ORAL

Dosage Strength : 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 18211

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

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OXYBUTYNIN CHLORIDE

Brand Name : OXYBUTYNIN CHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 1988-11-14

Application Number : 71655

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

USL PHARMA

United Kingdom
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United Kingdom
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OXYBUTYNIN CHLORIDE

Brand Name : OXYBUTYNIN CHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 1988-03-10

Application Number : 70746

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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