Details for New Drug Application (NDA): 090315
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NDA 090315 describes MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Fresenius Kabi Usa, Hospira, and Onesource Specialty, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE profile page.
The generic ingredient in MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE 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.
The generic ingredient in MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE 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 090315
| Tradename: | MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE |
| Applicant: | Onesource Specialty |
| Ingredient: | midazolam hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090315
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | midazolam hydrochloride | INJECTABLE;INJECTION | 090315 | ANDA | SOMERSET THERAPEUTICS, LLC | 70069-816 | 70069-816-10 | 10 VIAL in 1 CARTON (70069-816-10) / 2 mL in 1 VIAL |
| MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | midazolam hydrochloride | INJECTABLE;INJECTION | 090315 | ANDA | SOMERSET THERAPEUTICS, LLC | 70069-816 | 70069-816-25 | 25 VIAL in 1 CARTON (70069-816-25) / 2 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
| Approval Date: | Nov 29, 2010 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
| Approval Date: | Nov 29, 2010 | TE: | AP | RLD: | No | ||||
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