Details for New Drug Application (NDA): 020214
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NDA 020214 describes ZEMURON, which is a drug marketed by Organon Usa Inc and is included in one NDA. Additional details are available on the ZEMURON profile page.
The generic ingredient in ZEMURON is rocuronium bromide. There are eleven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the rocuronium bromide profile page.
The generic ingredient in ZEMURON is rocuronium bromide. There are eleven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the rocuronium bromide profile page.
Summary for 020214
| Tradename: | ZEMURON |
| Applicant: | Organon Usa Inc |
| Ingredient: | rocuronium bromide |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 17, 1994 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 17, 1994 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 17, 1994 | TE: | RLD: | Yes | |||||
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