Details for New Drug Application (NDA): 075494
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The generic ingredient in MIDAZOLAM HYDROCHLORIDE 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 075494
Tradename: | MIDAZOLAM HYDROCHLORIDE |
Applicant: | Epic Pharma Llc |
Ingredient: | midazolam hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 075494
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 075494 | ANDA | Akorn | 17478-523 | 17478-523-02 | 10 VIAL in 1 CARTON (17478-523-02) / 2 mL in 1 VIAL |
MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 075494 | ANDA | Akorn | 17478-523 | 17478-523-05 | 10 VIAL in 1 CARTON (17478-523-05) / 5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
Approval Date: | Jun 30, 2000 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
Approval Date: | Jun 30, 2000 | TE: | AP | RLD: | No |
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