Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 008732

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PRO-BANTHINE (PROPANTHELINE BROMIDE)
7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: PROPANTHELINE BROMIDE
Proprietary Name: PRO-BANTHINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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: N008732
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SHIRE DEVELOPMENT INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
PRO-BANTHINE (PROPANTHELINE BROMIDE)
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: PROPANTHELINE BROMIDE
Proprietary Name: PRO-BANTHINE
Dosage Form; Route of Administration: TABLET; 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Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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: N008732
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SHIRE DEVELOPMENT INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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