Product Details for NDA 009193
COGENTIN (BENZTROPINE MESYLATE)
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BENZTROPINE MESYLATE
Proprietary Name: COGENTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N009193
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MERCK AND CO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
COGENTIN (BENZTROPINE MESYLATE)
Proprietary Name: COGENTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N009193
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MERCK AND CO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BENZTROPINE MESYLATE
Proprietary Name: COGENTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N009193
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MERCK AND CO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
COGENTIN (BENZTROPINE MESYLATE)
Proprietary Name: COGENTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG **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: N009193
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MERCK AND CO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BENZTROPINE MESYLATE
Proprietary Name: COGENTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG **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: N009193
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MERCK AND CO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: COGENTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG **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: N009193
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MERCK AND CO INC
Marketing Status: Discontinued
Patent and Exclusivity Information