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Details for New Drug Application (NDA): 021721

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NDA 021721 describes LEVAQUIN, which is a drug marketed by Janssen Pharms and is included in three NDAs. It is available from eleven suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the LEVAQUIN profile page.

The generic ingredient in LEVAQUIN is levofloxacin. There are twenty-eight drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the levofloxacin profile page.

Summary for NDA: 021721

Janssen Pharms
Therapeutic Class:Antibacterials

Suppliers and Packaging for NDA: 021721

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;ORAL 021721 NDA AUTHORIZED GENERIC Patriot Pharmaceuticals, Inc. 10147-0941 10147-0941-6 1 BOTTLE in 1 CARTON (10147-0941-6) > 480 mL in 1 BOTTLE
SOLUTION;ORAL 021721 NDA Janssen Pharmaceuticals, Inc. 50458-170 50458-170-01 480 mL in 1 BOTTLE (50458-170-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength250MG/10ML
Approval Date:Oct 21, 2004TE:AARLD:Yes
Patent:6,806,256*PEDPatent Expiration:Aug 26, 2022Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021721

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
SOLUTION;ORAL021721-001Oct 21, 20045,053,407*PED<disabled>
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