Product Details for NDA 007959
TENSILON (EDROPHONIUM CHLORIDE)
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: EDROPHONIUM CHLORIDE
Proprietary Name: TENSILON
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N007959
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
TENSILON PRESERVATIVE FREE (EDROPHONIUM CHLORIDE)
Proprietary Name: TENSILON
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N007959
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: EDROPHONIUM CHLORIDE
Proprietary Name: TENSILON PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N007959
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: TENSILON PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/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: N007959
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status: Discontinued
Patent and Exclusivity Information