Details for New Drug Application (NDA): 090316
✉ Email this page to a colleague
NDA 090316 describes MIDOZALAM HYDROCHLORIDE, which is a drug marketed by Steriscience and is included in one NDA. It is available from two suppliers. Additional details are available on the MIDOZALAM HYDROCHLORIDE profile page.
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.
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 | ||||
Complete Access Available with Subscription
