Details for New Drug Application (NDA): 075873
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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 075873
Tradename: | MIDAZOLAM HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | midazolam hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 075873
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | SYRUP;ORAL | 075873 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-3566 | 0054-3566-99 | 118 mL in 1 BOTTLE, GLASS (0054-3566-99) |
MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | SYRUP;ORAL | 075873 | ANDA | Major Pharmaceuticals | 0904-7113 | 0904-7113-93 | 30 CUP, UNIT-DOSE in 1 CASE (0904-7113-93) / 5 mL in 1 CUP, UNIT-DOSE (0904-7113-41) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | EQ 2MG BASE/ML | ||||
Approval Date: | Apr 30, 2002 | TE: | AA | RLD: | No |
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