Details for New Drug Application (NDA): 209566
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NDA 209566 describes SEIZALAM, which is a drug marketed by MMT and is included in one NDA. 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-four 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-four 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 |
Medical Subject Heading (MeSH) Categories for 209566
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | 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 | ||||||||
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