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Details for New Drug Application (NDA): 020634

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NDA 020634 describes LEVAQUIN, which is a drug marketed by Janssen Pharms and is included in three NDAs. It is available from ten 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-nine 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: 020634

Tradename:
LEVAQUIN
Applicant:
Janssen Pharms
Ingredient:
levofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 020634

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 020634

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVAQUIN
levofloxacin
TABLET;ORAL 020634 NDA Rebel Distributors Corp 21695-464 21695-464-07 7 TABLET, FILM COATED in 1 BOTTLE (21695-464-07)
LEVAQUIN
levofloxacin
TABLET;ORAL 020634 NDA Rebel Distributors Corp 21695-519 21695-519-07 7 TABLET, FILM COATED in 1 BOTTLE (21695-519-07)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Dec 20, 1996TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Dec 20, 1996TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Sep 8, 2000TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020634

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
LEVAQUIN
levofloxacin
TABLET;ORAL020634-001Dec 20, 19964,382,892► subscribe
Janssen Pharms
LEVAQUIN
levofloxacin
TABLET;ORAL020634-003Sep 8, 20005,053,407*PED► subscribe
Janssen Pharms
LEVAQUIN
levofloxacin
TABLET;ORAL020634-002Dec 20, 19965,053,407*PED► subscribe
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