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Details for New Drug Application (NDA): 077753

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NDA 077753 describes CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Bedford, Claris, Hikma Farmaceutica, Teva Pharms, Acs Dobfar Info Sa, Hospira, and Baxter Hlthcare, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER is ciprofloxacin. There are thirty-one drug master file entries for this compound. Ten suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the ciprofloxacin profile page.

Summary for NDA: 077753

Tradename:
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:
Hospira
Ingredient:
ciprofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 077753

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 077753

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION 077753 ANDA Hospira, Inc. 0409-4777 0409-4777-02 24 POUCH in 1 CASE (0409-4777-02) > 1 BAG in 1 POUCH > 200 mL in 1 BAG
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION 077753 ANDA Hospira, Inc. 0409-4777 0409-4777-23 24 POUCH in 1 CASE (0409-4777-23) > 1 BAG in 1 POUCH > 100 mL in 1 BAG

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML
Approval Date:Mar 18, 2008TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength400MG/200ML
Approval Date:Mar 18, 2008TE:APRLD:No


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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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