Details for New Drug Application (NDA): 216159
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NDA 216159 describes MIDAZOLAM IN 0.9% SODIUM CHLORIDE, which is a drug marketed by Gland Pharma Ltd, Hikma, and Inforlife, and is included in three NDAs. It is available from three suppliers. There is one patent protecting this drug. Additional details are available on the MIDAZOLAM IN 0.9% SODIUM CHLORIDE profile page.
The generic ingredient in MIDAZOLAM IN 0.9% 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 0.9% 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 216159
| Tradename: | MIDAZOLAM IN 0.9% SODIUM CHLORIDE |
| Applicant: | Hikma |
| Ingredient: | midazolam |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216159
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 216159 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9379 | 0143-9379-10 | 10 POUCH in 1 CARTON (0143-9379-10) / 1 BAG in 1 POUCH (0143-9379-01) / 50 mL in 1 BAG |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 216159 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9380 | 0143-9380-10 | 10 POUCH in 1 CARTON (0143-9380-10) / 1 BAG in 1 POUCH (0143-9380-01) / 100 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/50ML (1MG/ML) | ||||
| Approval Date: | Apr 17, 2023 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jan 2, 2024 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/100ML (1MG/ML) | ||||
| Approval Date: | Apr 17, 2023 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jan 2, 2024 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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