Details for New Drug Application (NDA): 075857
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The generic ingredient in MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.
Summary for 075857
Tradename: | MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE |
Applicant: | Hospira |
Ingredient: | midazolam hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 075857
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | midazolam hydrochloride | INJECTABLE;INJECTION | 075857 | ANDA | Henry Schein, Inc. | 0404-9916 | 0404-9916-01 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9916-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | midazolam hydrochloride | INJECTABLE;INJECTION | 075857 | ANDA | Henry Schein, Inc. | 0404-9916 | 0404-9916-02 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9916-02) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
Approval Date: | Jul 22, 2002 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
Approval Date: | Jul 22, 2002 | TE: | AP | RLD: | No |
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