Details for New Drug Application (NDA): 206687
NDA 206687 describes SODIUM ACETATE, which is a drug marketed by Amneal, Dr Reddys, Fresenius Kabi Usa, Hikma, Hospira, Milla Pharms, and Somerset Theraps Llc, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the SODIUM ACETATE profile page.
The generic ingredient in SODIUM ACETATE is sodium acetate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium acetate profile page.
The generic ingredient in SODIUM ACETATE is sodium acetate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium acetate profile page.
Summary for 206687
| Tradename: | SODIUM ACETATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | sodium acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206687
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM ACETATE | sodium acetate | SOLUTION;INTRAVENOUS | 206687 | ANDA | Fresenius Kabi USA, LLC | 63323-032 | 63323-032-00 | 20 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-032-00) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-032-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 400MEQ/100ML (4MEQ/ML) | ||||
| Approval Date: | Oct 30, 2017 | TE: | AP | RLD: | No | ||||
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