Details for New Drug Application (NDA): 216359
✉ Email this page to a colleague
The generic ingredient in MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-five 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: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML) | ||||
Approval Date: | Aug 8, 2022 | TE: | RLD: | Yes |
Complete Access Available with Subscription