Product Details for NDA 006536
URECHOLINE (BETHANECHOL CHLORIDE)
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BETHANECHOL CHLORIDE
Proprietary Name: URECHOLINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N006536
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ODYSSEY PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
URECHOLINE (BETHANECHOL CHLORIDE)
Proprietary Name: URECHOLINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N006536
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ODYSSEY PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BETHANECHOL CHLORIDE
Proprietary Name: URECHOLINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N006536
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ODYSSEY PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
URECHOLINE (BETHANECHOL CHLORIDE)
Proprietary Name: URECHOLINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 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: N006536
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ODYSSEY PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BETHANECHOL CHLORIDE
Proprietary Name: URECHOLINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **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: N006536
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ODYSSEY PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
URECHOLINE (BETHANECHOL CHLORIDE)
Proprietary Name: URECHOLINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **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: N006536
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ODYSSEY PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BETHANECHOL CHLORIDE
Proprietary Name: URECHOLINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG **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: N006536
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ODYSSEY PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
URECHOLINE (BETHANECHOL CHLORIDE)
Proprietary Name: URECHOLINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG **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: N006536
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ODYSSEY PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BETHANECHOL CHLORIDE
Proprietary Name: URECHOLINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG **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: N006536
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ODYSSEY PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: URECHOLINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG **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: N006536
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ODYSSEY PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information