Details for New Drug Application (NDA): 215868
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NDA 215868 describes MIDAZOLAM IN 0.8% SODIUM CHLORIDE, which is a drug marketed by B Braun Medical and Exela Pharma and is included in two NDAs. It is available from one supplier. Additional details are available on the MIDAZOLAM IN 0.8% SODIUM CHLORIDE profile page.
The generic ingredient in MIDAZOLAM IN 0.8% SODIUM CHLORIDE is midazolam. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the midazolam profile page.
The generic ingredient in MIDAZOLAM IN 0.8% SODIUM CHLORIDE is midazolam. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the midazolam profile page.
Summary for 215868
| Tradename: | MIDAZOLAM IN 0.8% SODIUM CHLORIDE |
| Applicant: | Exela Pharma |
| Ingredient: | midazolam |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 20, 2022 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/100ML (1MG/ML) | ||||
| Approval Date: | Jul 20, 2022 | TE: | RLD: | Yes | |||||
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