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Details for New Drug Application (NDA): 018654

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NDA 018654 describes VERSED, which is a drug marketed by Roche and HLR and is included in two NDAs. Additional details are available on the VERSED profile page.

The generic ingredient in VERSED is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.

Summary for NDA: 018654

midazolam hydrochloride

Summary for product number 001

Approval Date:Dec 20, 1985TE:RLD:No

Summary for product number 002

Approval Date:May 26, 1987TE:RLD:No

Expired Orange Book Patents for NDA: 018654

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
midazolam hydrochloride
INJECTABLE;INJECTION018654-002May 26, 19874,280,957*PED► subscribe
midazolam hydrochloride
INJECTABLE;INJECTION018654-001Dec 20, 19854,280,957*PED► subscribe
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