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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 nine 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. Sixty-two 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:
1
Applicant:
1
Ingredient:
1
Patents:1
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:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Dec 20, 1996TE:ABRLD:Yes

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
Janssen Pharms
LEVAQUIN
levofloxacin
TABLET;ORAL020634-001Dec 20, 19965,053,407*PED► Subscribe
Janssen Pharms
LEVAQUIN
levofloxacin
TABLET;ORAL020634-002Dec 20, 19964,382,892► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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