Details for New Drug Application (NDA): 020214
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The generic ingredient in ZEMURON is rocuronium bromide. There are eleven drug master file entries for this compound. Thirteen 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 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/5ML (10MG/ML) | ||||
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) | ||||
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) | ||||
Approval Date: | Mar 17, 1994 | TE: | RLD: | Yes |
Expired US Patents for NDA 020214
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon Usa Inc | ZEMURON | rocuronium bromide | INJECTABLE;INJECTION | 020214-001 | Mar 17, 1994 | See Plans and Pricing | See Plans and Pricing |
Organon Usa Inc | ZEMURON | rocuronium bromide | INJECTABLE;INJECTION | 020214-003 | Mar 17, 1994 | See Plans and Pricing | See Plans and Pricing |
Organon Usa Inc | ZEMURON | rocuronium bromide | INJECTABLE;INJECTION | 020214-002 | Mar 17, 1994 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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