Details for New Drug Application (NDA): 090316
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The generic ingredient in MIDOZALAM 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 090316
Tradename: | MIDOZALAM HYDROCHLORIDE |
Applicant: | Steriscience |
Ingredient: | midazolam hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 090316
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MIDOZALAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 090316 | ANDA | SOMERSET THERAPEUTICS, LLC | 70069-818 | 70069-818-10 | 10 VIAL in 1 CARTON (70069-818-10) / 10 mL in 1 VIAL |
MIDOZALAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 090316 | ANDA | Steriscience Specialties Private Limited | 82449-207 | 82449-207-02 | 10 VIAL in 1 CARTON (82449-207-02) / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
Approval Date: | May 4, 2011 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
Approval Date: | May 4, 2011 | TE: | AP | RLD: | No |
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