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Last Updated: May 31, 2020

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Details for New Drug Application (NDA): 204968


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NDA 204968 describes LEVOFLOXACIN, which is a drug marketed by Akorn, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms Ltd, Hospira Inc, Mylan Asi, Zydus Pharms, Apotex Inc, Micro Labs Ltd India, Mylan Labs Ltd, Rising, Watson Labs Teva, Hi Tech Pharma, Lannett Co Inc, Celltrion, Cipla Ltd, Dr Reddys Labs Inc, Glenmark Generics, Hec Pharm, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Sandoz, Teva, Torrent Pharms, Watson Labs Inc, Zydus Pharms Usa Inc, Fresenius Kabi Usa, Hikma Farmaceutica, and Inforlife, and is included in forty NDAs. It is available from forty-seven suppliers. Additional details are available on the LEVOFLOXACIN profile page.

The generic ingredient in LEVOFLOXACIN is levofloxacin. There are thirty-one drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
Summary for 204968
Tradename:LEVOFLOXACIN
Applicant:Hec Pharm
Ingredient:levofloxacin
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204968
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN levofloxacin TABLET;ORAL 204968 ANDA Sunshine Lake Pharma CO., LTD. 48792-7814 48792-7814-1 50 TABLET, FILM COATED in 1 BOTTLE (48792-7814-1)
LEVOFLOXACIN levofloxacin TABLET;ORAL 204968 ANDA Sunshine Lake Pharma CO., LTD. 48792-7815 48792-7815-1 50 TABLET, FILM COATED in 1 BOTTLE (48792-7815-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Feb 5, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Feb 5, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Feb 5, 2019TE:ABRLD:No

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