Details for New Drug Application (NDA): 019445
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NDA 019445 describes DEXTROSE 50%, which is a drug marketed by Hospira, Intl Medication Sys, Baxter Hlthcare, and Icu Medical Inc, and is included in six NDAs. It is available from six suppliers. Additional details are available on the DEXTROSE 50% profile page.
The generic ingredient in DEXTROSE 50% is dextrose. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dextrose profile page.
The generic ingredient in DEXTROSE 50% is dextrose. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dextrose profile page.
Summary for 019445
| Tradename: | DEXTROSE 50% |
| Applicant: | Hospira |
| Ingredient: | dextrose |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 019445
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 25% | dextrose | INJECTABLE;INJECTION | 019445 | NDA | Henry Schein, Inc. | 0404-9844 | 0404-9844-10 | 1 SYRINGE in 1 BAG (0404-9844-10) / 10 mL in 1 SYRINGE |
| DEXTROSE 25% | dextrose | INJECTABLE;INJECTION | 019445 | NDA | Henry Schein, Inc. | 0404-9845 | 0404-9845-50 | 1 SYRINGE in 1 BAG (0404-9845-50) / 50 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/ML | ||||
| Approval Date: | Jun 3, 1986 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 250MG/ML | ||||
| Approval Date: | Nov 23, 1998 | TE: | RLD: | Yes | |||||
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