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Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203613

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NDA 203613 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 Teva, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Sandoz, Macleods Pharms Ltd, Akorn, Glenmark Generics, Zydus Pharms Usa Inc, Sagent Agila Llc, Teva, Wockhardt, Mylan, Hospira Inc, Hi Tech Pharma, Apotex Inc, Watson Labs Inc, Emcure Pharms Ltd, Cipla Ltd, Acs Dobfar Info Sa, Fresenius Kabi Usa, and Hikma Farmaceutica, and is included in thirty-six NDAs. It is available from fifty-seven 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. Sixty-three suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.

Summary for NDA: 203613

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 203613

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN
levofloxacin
TABLET;ORAL 203613 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-513 59746-513-06 100 TABLET, FILM COATED in 1 BOTTLE (59746-513-06)
LEVOFLOXACIN
levofloxacin
TABLET;ORAL 203613 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-513 59746-513-14 50 TABLET, FILM COATED in 1 BOTTLE (59746-513-14)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jun 19, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jun 19, 2015TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Fuji
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Cipla
Express Scripts
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US Department of Justice

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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