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Details for New Drug Application (NDA): 019384

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NDA 019384 describes NOROXIN, which is a drug marketed by Merck and is included in one NDA. Additional details are available on the NOROXIN profile page.

The generic ingredient in NOROXIN is norfloxacin. There are seven drug master file entries for this compound. Additional details are available on the norfloxacin profile page.

Summary for NDA: 019384

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength400MG
Approval Date:Oct 31, 1986TE:RLD:No

Expired Orange Book Patents for NDA: 019384

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
TABLET;ORAL019384-002Oct 31, 19864,146,719<subscribe>
TABLET;ORAL019384-002Oct 31, 19864,639,458<subscribe>
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