Details for New Drug Application (NDA): 019345
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NDA 019345 describes DEXTROSE 30% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and Icu Medical Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the DEXTROSE 30% IN PLASTIC CONTAINER profile page.
The generic ingredient in DEXTROSE 30% 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 30% 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 019345
| Tradename: | DEXTROSE 30% IN PLASTIC CONTAINER |
| Applicant: | Icu Medical Inc |
| Ingredient: | dextrose |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 019345
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 30% IN PLASTIC CONTAINER | dextrose | INJECTABLE;INJECTION | 019345 | NDA | ICU Medical Inc. | 0990-8004 | 0990-8004-15 | 12 POUCH in 1 CASE (0990-8004-15) / 1 BAG in 1 POUCH / 500 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 30GM/100ML | ||||
| Approval Date: | Jan 26, 1985 | TE: | RLD: | Yes | |||||
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