Details for New Drug Application (NDA): 209448
NDA 209448 describes DEXTROSE 10% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Miles, and Otsuka Icu Medcl, and is included in eleven NDAs. It is available from six suppliers. Additional details are available on the DEXTROSE 10% IN PLASTIC CONTAINER profile page.
The generic ingredient in DEXTROSE 10% IN PLASTIC CONTAINER is dextrose. There are two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dextrose profile page.
The generic ingredient in DEXTROSE 10% IN PLASTIC CONTAINER is dextrose. There are two drug master file entries for this compound. Sixteen 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 |
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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