Details for New Drug Application (NDA): 203460
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NDA 203460 describes MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Fresenius Kabi Usa, Hospira, and Steriscience Speclts, and is included in three NDAs. It is available from six 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-five 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-five suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.
Summary for 203460
| Tradename: | MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | midazolam hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203460
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | midazolam hydrochloride | INJECTABLE;INJECTION | 203460 | ANDA | Fresenius Kabi USA, LLC | 76045-001 | 76045-001-20 | 24 BLISTER PACK in 1 CARTON (76045-001-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-001-00) / 2 mL in 1 SYRINGE, GLASS |
| MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | midazolam hydrochloride | INJECTABLE;INJECTION | 203460 | ANDA | Fresenius Kabi USA, LLC | 76045-002 | 76045-002-10 | 24 BLISTER PACK in 1 CARTON (76045-002-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-002-00) / 1 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
| Approval Date: | Aug 22, 2014 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
| Approval Date: | Aug 22, 2014 | TE: | AP | RLD: | No | ||||
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