Details for New Drug Application (NDA): 209566
✉ Email this page to a colleague
NDA 209566 describes SEIZALAM, which is a drug marketed by MMT and is included in one NDA. It is available from one supplier. Additional details are available on the SEIZALAM profile page.
The generic ingredient in SEIZALAM 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 SEIZALAM 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 209566
| Tradename: | SEIZALAM |
| Applicant: | Mmt |
| Ingredient: | midazolam hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209566
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEIZALAM | midazolam hydrochloride | SOLUTION;INTRAMUSCULAR | 209566 | NDA | Meridian Medical Technologies LLC | 11704-650 | 11704-650-10 | 10 VIAL, GLASS in 1 CARTON (11704-650-10) / 10 mL in 1 VIAL, GLASS (11704-650-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | EQ 50MG BASE/10ML (EQ 5MG BASE/ML) | ||||
| Approval Date: | Sep 14, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 14, 2025 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF STATUS EPILEPTICUS IN ADULTS | ||||||||
Complete Access Available with Subscription
