Details for New Drug Application (NDA): 020047
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NDA 020047 describes DEXTROSE 70% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, and Icu Medical Inc, and is included in five NDAs. It is available from three suppliers. Additional details are available on the DEXTROSE 70% IN PLASTIC CONTAINER profile page.
The generic ingredient in DEXTROSE 70% 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 70% 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 020047
| Tradename: | DEXTROSE 70% IN PLASTIC CONTAINER |
| Applicant: | Baxter Hlthcare |
| Ingredient: | dextrose |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020047
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 50% IN PLASTIC CONTAINER | dextrose | INJECTABLE;INJECTION | 020047 | NDA | Baxter Healthcare Corporation | 0338-0719 | 0338-0719-06 | 2000 mL in 1 BAG (0338-0719-06) |
| DEXTROSE 60% IN PLASTIC CONTAINER | dextrose | INJECTABLE;INJECTION | 020047 | NDA | Baxter Healthcare Corporation | 0338-0719 | 0338-0719-06 | 2000 mL in 1 BAG (0338-0719-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50GM/100ML | ||||
| Approval Date: | Jul 2, 1991 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 60GM/100ML | ||||
| Approval Date: | Jul 2, 1991 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 70GM/100ML | ||||
| Approval Date: | Jul 2, 1991 | TE: | AP | RLD: | Yes | ||||
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