Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202328

« Back to Dashboard
NDA 202328 describes LEVOFLOXACIN, which is a drug marketed by Rising Pharms Inc, Orchid Hlthcare, Hetero Labs Ltd V, Dr Reddys Labs Inc, Jubilant Generics, Torrent Pharms, Lupin, Watson Labs Inc, Aurobindo Pharma Ltd, Claris, Sandoz, Macleods Pharms Ltd, Akorn, Glenmark Generics, Zydus Pharms Usa Inc, Sagent Pharms, Teva, Wockhardt, Mylan, Hospira Inc, Hi Tech Pharma, Apotex Inc, Emcure Pharms Ltd, Cipla Ltd, Acs Dobfar Info Sa, Fresenius Kabi Usa, and Hikma Farmaceutica, and is included in thirty-five NDAs. It is available from fifty-one suppliers. Additional details are available on the LEVOFLOXACIN profile page.

The generic ingredient in LEVOFLOXACIN is levofloxacin. There are twenty-eight drug master file entries for this compound. Fifty-eight 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: 202328

Aurobindo Pharma Ltd
Therapeutic Class:Antibacterials

Suppliers and Packaging for NDA: 202328

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 202328 ANDA AuroMedics Pharma LLC 55150-156 55150-156-20 1 VIAL, SINGLE-USE in 1 CARTON (55150-156-20) > 20 mL in 1 VIAL, SINGLE-USE
INJECTABLE;INJECTION 202328 ANDA AuroMedics Pharma LLC 55150-157 55150-157-30 1 VIAL, SINGLE-USE in 1 CARTON (55150-157-30) > 30 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG/20ML (EQ 25MG/ML)
Approval Date:Jan 24, 2013TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 750MG/30ML (EQ 25MG/ML)
Approval Date:Jan 24, 2013TE:APRLD:No

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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.