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Last Updated: May 29, 2020

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Details for New Drug Application (NDA): 091678

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NDA 091678 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 091678
Applicant:Hi Tech Pharma
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 091678
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN levofloxacin SOLUTION;ORAL 091678 ANDA Hi-Tech Pharmacal Co., Inc. 50383-286 50383-286-04 1 BOTTLE in 1 CARTON (50383-286-04) > 100 mL in 1 BOTTLE
LEVOFLOXACIN levofloxacin SOLUTION;ORAL 091678 ANDA Hi-Tech Pharmacal Co., Inc. 50383-286 50383-286-08 1 BOTTLE in 1 CARTON (50383-286-08) > 200 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength250MG/10ML
Approval Date:Jun 20, 2011TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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