Details for New Drug Application (NDA): 076379
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The generic ingredient in MIDAZOLAM HYDROCHLORIDE is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.
Summary for 076379
Tradename: | MIDAZOLAM HYDROCHLORIDE |
Applicant: | Padagis Us |
Ingredient: | midazolam hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076379
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | SYRUP;ORAL | 076379 | ANDA | Padagis US LLC | 0574-0150 | 0574-0150-04 | 1 BOTTLE, GLASS in 1 CARTON (0574-0150-04) / 118 mL in 1 BOTTLE, GLASS |
MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | SYRUP;ORAL | 076379 | ANDA | Bryant Ranch Prepack | 63629-2534 | 63629-2534-1 | 1 BOTTLE, GLASS in 1 CARTON (63629-2534-1) / 118 mL in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | EQ 2MG BASE/ML | ||||
Approval Date: | May 2, 2005 | TE: | AA | RLD: | No |
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