Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 008922

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CALCIUM DISODIUM VERSENATE (EDETATE CALCIUM DISODIUM)
200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: EDETATE CALCIUM DISODIUM
Proprietary Name: CALCIUM DISODIUM VERSENATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N008922
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

CALCIUM DISODIUM VERSENATE (EDETATE CALCIUM DISODIUM)
500MG
Marketing Status: Discontinued

Active Ingredient: EDETATE CALCIUM DISODIUM
Proprietary Name: CALCIUM DISODIUM VERSENATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N008922
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information