Details for New Drug Application (NDA): 209448
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The generic ingredient in DEXTROSE 10% IN PLASTIC CONTAINER 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 209448
Tradename: | DEXTROSE 10% IN PLASTIC CONTAINER |
Applicant: | Fresenius Kabi Usa |
Ingredient: | dextrose |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 209448
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXTROSE 10% IN PLASTIC CONTAINER | dextrose | INJECTABLE;INJECTION | 209448 | ANDA | Becton Dickinson and Company | 17271-721 | 17271-721-05 | 30 BAG in 1 CASE (17271-721-05) / 250 mL in 1 BAG |
DEXTROSE 10% IN PLASTIC CONTAINER | dextrose | INJECTABLE;INJECTION | 209448 | ANDA | Becton Dickinson and Company | 17271-721 | 17271-721-06 | 20 BAG in 1 CASE (17271-721-06) / 500 mL in 1 BAG |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10GM/100ML | ||||
Approval Date: | Jul 16, 2018 | TE: | AP | RLD: | No |
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