Product Details for NDA 008732
PRO-BANTHINE (PROPANTHELINE BROMIDE)
7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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)
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Strength: 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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