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Generated: November 15, 2018

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Details for New Drug Application (NDA): 078024

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NDA 078024 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 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. Additional details are available on the ciprofloxacin profile page.
Summary for 078024
Tradename:CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:Baxter Hlthcare Corp
Ingredient:ciprofloxacin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078024
Ingredient-typeQuinolones
Medical Subject Heading (MeSH) Categories for 078024
Suppliers and Packaging for NDA: 078024
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 078024 ANDA Pfizer Labs, Division of Pfizer Inc 0069-4395 0069-4395-19 100 mL in 1 BAG (0069-4395-19)
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 078024 ANDA Pfizer Labs, Division of Pfizer Inc 0069-4396 0069-4396-27 200 mL in 1 BAG (0069-4396-27)

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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