Details for New Drug Application (NDA): 216359
NDA 216359 describes MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR), which is a drug marketed by Rafa Labs Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) profile page.
The generic ingredient in MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) is midazolam hydrochloride. There is one drug master file entry for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.
The generic ingredient in MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) is midazolam hydrochloride. There is one drug master file entry for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.
Summary for 216359
| Tradename: | MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) |
| Applicant: | Rafa Labs Ltd |
| Ingredient: | midazolam hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216359
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) | midazolam hydrochloride | SOLUTION;INTRAMUSCULAR | 216359 | NDA | Rafa Laboratories, Ltd. | 71053-595 | 71053-595-01 | 480 CARTON in 1 BOX (71053-595-01) / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML) | ||||
| Approval Date: | Aug 8, 2022 | TE: | RLD: | Yes | |||||
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