Details for New Drug Application (NDA): 016694
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NDA 016694 describes DEXTROSE 10% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Icu Medical Inc, and Miles, and is included in eleven NDAs. It is available from five suppliers. Additional details are available on the DEXTROSE 10% IN PLASTIC CONTAINER profile page.
The generic ingredient in DEXTROSE 10% IN PLASTIC CONTAINER is dextrose. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dextrose profile page.
The generic ingredient in DEXTROSE 10% IN PLASTIC CONTAINER is dextrose. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dextrose profile page.
Summary for 016694
| Tradename: | DEXTROSE 10% IN PLASTIC CONTAINER |
| Applicant: | Baxter Hlthcare |
| Ingredient: | dextrose |
| Patents: | 0 |
Suppliers and Packaging for NDA: 016694
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 10% IN PLASTIC CONTAINER | dextrose | INJECTABLE;INJECTION | 016694 | NDA | Baxter Healthcare Corporation | 0338-0023 | 0338-0023-02 | 250 mL in 1 BAG (0338-0023-02) |
| DEXTROSE 10% IN PLASTIC CONTAINER | dextrose | INJECTABLE;INJECTION | 016694 | NDA | Baxter Healthcare Corporation | 0338-0023 | 0338-0023-03 | 500 mL in 1 BAG (0338-0023-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10GM/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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