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Generated: January 23, 2019

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Details for New Drug Application (NDA): 078252

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NDA 078252 describes CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare, Baxter Hlthcare Corp, Bedford, Hikma Farmaceutica, Hospira, Inforlife, and Teva Pharms, and is included in seven NDAs. It is available from five 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-four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ciprofloxacin profile page.
Summary for 078252
Tradename:CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:Inforlife
Ingredient:ciprofloxacin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078252
Medical Subject Heading (MeSH) Categories for 078252
Suppliers and Packaging for NDA: 078252
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 078252 ANDA Sandoz Inc 0781-3239 0781-3239-09 24 POUCH in 1 CARTON (0781-3239-09) > 1 BAG in 1 POUCH (0781-3239-46) > 100 mL in 1 BAG
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 078252 ANDA Sandoz Inc 0781-3240 0781-3240-09 24 POUCH in 1 CARTON (0781-3240-09) > 1 BAG in 1 POUCH (0781-3240-48) > 200 mL in 1 BAG

Profile for product number 001

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

Profile for product number 002

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

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