Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078503

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OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
5MG
Marketing Status: Prescription

Active Ingredient: OXYBUTYNIN CHLORIDE
Proprietary Name: OXYBUTYNIN CHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078503
Product Number: 001
Approval Date: Feb 4, 2009
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
10MG
Marketing Status: Prescription

Active Ingredient: OXYBUTYNIN CHLORIDE
Proprietary Name: OXYBUTYNIN CHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078503
Product Number: 002
Approval Date: Feb 4, 2009
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
15MG
Marketing Status: Prescription

Active Ingredient: OXYBUTYNIN CHLORIDE
Proprietary Name: OXYBUTYNIN CHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078503
Product Number: 003
Approval Date: Feb 4, 2009
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information