Details for New Drug Application (NDA): 018563
NDA 018563 describes DEXTROSE 50% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare, Icu Medical Inc, and Otsuka Icu Medcl, and is included in four NDAs. It is available from two suppliers. Additional details are available on the DEXTROSE 50% IN PLASTIC CONTAINER profile page.
The generic ingredient in DEXTROSE 50% IN PLASTIC CONTAINER is dextrose. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dextrose profile page.
The generic ingredient in DEXTROSE 50% IN PLASTIC CONTAINER is dextrose. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dextrose profile page.
Summary for 018563
| Tradename: | DEXTROSE 50% IN PLASTIC CONTAINER |
| Applicant: | Otsuka Icu Medcl |
| Ingredient: | dextrose |
| Patents: | 0 |
Suppliers and Packaging for NDA: 018563
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 50% IN PLASTIC CONTAINER | dextrose | INJECTABLE;INJECTION | 018563 | NDA | ICU Medical Inc. | 0990-7936 | 0990-7936-19 | 12 POUCH in 1 CASE (0990-7936-19) / 1 BAG in 1 POUCH / 500 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50GM/100ML | ||||
| Approval Date: | Mar 23, 1982 | TE: | AP | RLD: | Yes | ||||
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