Details for New Drug Application (NDA): 203451
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NDA 203451 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 seven 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the dextrose profile page.
Summary for 203451
| Tradename: | DEXTROSE 50% |
| Applicant: | Intl Medication Sys |
| Ingredient: | dextrose |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203451
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 50% | dextrose | INJECTABLE;INJECTION | 203451 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1584 | 51662-1584-1 | 1 SYRINGE in 1 CARTON (51662-1584-1) / 50 mL in 1 SYRINGE |
| DEXTROSE 50% | dextrose | INJECTABLE;INJECTION | 203451 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1584 | 51662-1584-3 | 10 POUCH in 1 CASE (51662-1584-3) / 1 SYRINGE in 1 POUCH (51662-1584-2) / 50 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/ML | ||||
| Approval Date: | Mar 26, 2021 | TE: | AP | RLD: | No | ||||
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