Details for New Drug Application (NDA): 016367
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NDA 016367 describes DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare, Icu Medical Inc, Hospira, B Braun, Miles, Abbott, Fresenius Kabi Usa, and DHL, and is included in forty-nine NDAs. It is available from seven suppliers. Additional details are available on the DEXTROSE 5% IN PLASTIC CONTAINER profile page.
The generic ingredient in DEXTROSE 5% IN PLASTIC CONTAINER is dextrose; potassium chloride; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.
The generic ingredient in DEXTROSE 5% IN PLASTIC CONTAINER is dextrose; potassium chloride; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.
Summary for 016367
| Tradename: | DEXTROSE 5% IN PLASTIC CONTAINER |
| Applicant: | Icu Medical Inc |
| Ingredient: | dextrose |
| Patents: | 0 |
Suppliers and Packaging for NDA: 016367
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% IN PLASTIC CONTAINER | dextrose | INJECTABLE;INJECTION | 016367 | NDA | ICU Medical Inc. | 0990-7922 | 0990-7922-02 | 24 POUCH in 1 CASE (0990-7922-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG |
| DEXTROSE 5% IN PLASTIC CONTAINER | dextrose | INJECTABLE;INJECTION | 016367 | NDA | ICU Medical Inc. | 0990-7922 | 0990-7922-03 | 24 POUCH in 1 CASE (0990-7922-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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