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Generated: December 10, 2018

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Details for New Drug Application (NDA): 076710

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NDA 076710 describes LEVOFLOXACIN, which is a drug marketed by Akorn, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms Ltd, Hospira Inc, Mylan Asi, Zydus Pharms Usa Inc, Anda Repository, Apotex Inc, Mylan Labs Ltd, Watson Labs Teva, Hi Tech Pharma, Lannett Co Inc, Cipla Ltd, Dr Reddys Labs Inc, Glenmark Generics, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Sandoz, Teva, Torrent Pharms, Watson Labs Inc, Wockhardt, Fresenius Kabi Usa, Hikma Farmaceutica, and Inforlife, and is included in thirty-eight NDAs. It is available from sixty-three suppliers. Additional details are available on the LEVOFLOXACIN profile page.

The generic ingredient in LEVOFLOXACIN is levofloxacin. There are thirty drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
Summary for 076710
Tradename:LEVOFLOXACIN
Applicant:Dr Reddys Labs Inc
Ingredient:levofloxacin
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076710
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Major Pharmaceuticals 0904-6351 0904-6351-61 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0904-6351-61)
LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Major Pharmaceuticals 0904-6352 0904-6352-61 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0904-6352-61)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jun 20, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jun 20, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Jun 20, 2011TE:ABRLD:No

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