Details for New Drug Application (NDA): 008922
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NDA 008922 describes CALCIUM DISODIUM VERSENATE, which is a drug marketed by Bausch and is included in one NDA. Additional details are available on the CALCIUM DISODIUM VERSENATE profile page.
The generic ingredient in CALCIUM DISODIUM VERSENATE is edetate calcium disodium. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the edetate calcium disodium profile page.
The generic ingredient in CALCIUM DISODIUM VERSENATE is edetate calcium disodium. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the edetate calcium disodium profile page.
Summary for 008922
| Tradename: | CALCIUM DISODIUM VERSENATE |
| Applicant: | Bausch |
| Ingredient: | edetate calcium disodium |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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