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 two 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. Four suppliers are listed for this compound. Additional details are available on the ciprofloxacin 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. Four 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 |
Pharmacology for NDA: 078252
| Mechanism of Action | Cytochrome P450 1A2 Inhibitors |
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 | Hospira, Inc. | 0409-2300 | 0409-2300-24 | 24 POUCH in 1 CARTON (0409-2300-24) / 1 BAG in 1 POUCH (0409-2300-01) / 100 mL in 1 BAG |
| CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | ciprofloxacin | INJECTABLE;INJECTION | 078252 | ANDA | Hospira, Inc. | 0409-3300 | 0409-3300-24 | 24 POUCH in 1 CARTON (0409-3300-24) / 1 BAG in 1 POUCH (0409-3300-01) / 200 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/100ML | ||||
| Approval Date: | Mar 18, 2008 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 400MG/200ML | ||||
| Approval Date: | Mar 18, 2008 | TE: | AP | RLD: | No | ||||
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