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 Exela Pharma and is included in one NDA. 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. Five 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. Five 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 |
Suppliers and Packaging for NDA: 215868
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIDAZOLAM IN 0.8% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 215868 | NDA | Exela Pharma Sciences, LLC | 51754-2130 | 51754-2130-4 | 25 VIAL in 1 CARTON (51754-2130-4) / 50 mL in 1 VIAL |
| MIDAZOLAM IN 0.8% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 215868 | NDA | Exela Pharma Sciences, LLC | 51754-2131 | 51754-2131-4 | 25 VIAL in 1 CARTON (51754-2131-4) / 100 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/50ML (1MG/ML) | ||||
| Approval Date: | Jul 20, 2022 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/100ML (1MG/ML) | ||||
| Approval Date: | Jul 20, 2022 | TE: | RLD: | Yes | |||||
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