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Generated: July 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077782

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NDA 077782 describes CIPROFLOXACIN, which is a drug marketed by Hikma Farmaceutica, Hospira, Claris, Lupin Ltd, Teva Pharms Usa, Fresenius Kabi Usa, Bedford Labs, Dr Reddys Labs Ltd, Actavis Labs Fl Inc, Sandoz, Anchen Pharms, Mylan Pharms Inc, Taro Pharm, Mylan, Barr, Carlsbad, Pliva, Apotex Inc, Teva, Nostrum Labs, Idt Australia Ltd, Unique Pharm Labs, Sun Pharm Inds Ltd, Teligent, Akorn Inc, Hikma, Aurobindo Pharma, Fdc Ltd, Watson Labs Inc, Rising Pharms Inc, Ivax Sub Teva Pharms, Watson Labs, Apotex, Amring Pharms, Bedford, Teva Pharms, Acs Dobfar Info Sa, and Baxter Hlthcare, and is included in forty-seven NDAs. It is available from four suppliers. Additional details are available on the CIPROFLOXACIN profile page.

The generic ingredient in CIPROFLOXACIN is ciprofloxacin hydrochloride. There are thirty-one drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.

Summary for NDA: 077782

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

Pharmacology for NDA: 077782

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 077782

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN
ciprofloxacin
 INJECTABLE;INJECTION 077782 ANDA Rebel Distributors Corp 21695-422 21695-422-01 20 mL in 1 VIAL (21695-422-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength200MG/20ML (10MG/ML)
Approval Date:Aug 28, 2006TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength400MG/40ML (10MG/ML)
Approval Date:Aug 28, 2006TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Fuji
Queensland Health
Healthtrust
Baxter
Express Scripts
Colorcon
Cantor Fitzgerald
UBS
Citi
Julphar

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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