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Details for New Drug Application (NDA): 021530

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NDA 021530 describes MOBIC, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the MOBIC profile page.

The generic ingredient in MOBIC is meloxicam. There are twenty-two drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the meloxicam profile page.

Summary for NDA: 021530

Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021530

Suppliers and Packaging for NDA: 021530

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSPENSION;ORAL 021530 NDA AUTHORIZED GENERIC Roxane Laboratories, Inc. 0054-0228 0054-0228-49 1 BOTTLE, GLASS in 1 CARTON (0054-0228-49) > 100 mL in 1 BOTTLE, GLASS
SUSPENSION;ORAL 021530 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0034 0597-0034-01 1 BOTTLE, GLASS in 1 CARTON (0597-0034-01) > 100 mL in 1 BOTTLE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength7.5MG/5ML
Approval Date:Jun 1, 2004TE:RLD:Yes
Patent:6,184,220*PEDPatent Expiration:Sep 25, 2019Product Flag?Substance Flag?Delist Request?Y

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