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Product Details for NDA 020897

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DITROPAN XL (OXYBUTYNIN CHLORIDE)
5MG
Marketing Status: Prescription
Active Ingredient: OXYBUTYNIN CHLORIDE
Proprietary Name: DITROPAN XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020897
Product Number: 001
Approval Date: Dec 16, 1998
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DITROPAN XL (OXYBUTYNIN CHLORIDE)
10MG
Marketing Status: Prescription
Active Ingredient: OXYBUTYNIN CHLORIDE
Proprietary Name: DITROPAN XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020897
Product Number: 002
Approval Date: Dec 16, 1998
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DITROPAN XL (OXYBUTYNIN CHLORIDE)
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: OXYBUTYNIN CHLORIDE
Proprietary Name: DITROPAN XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020897
Product Number: 003
Approval Date: Jun 22, 1999
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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