Details for New Drug Application (NDA): 214805
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The generic ingredient in SODIUM ACETATE is sodium acetate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sodium acetate profile page.
Summary for 214805
Tradename: | SODIUM ACETATE |
Applicant: | Milla Pharms |
Ingredient: | sodium acetate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 214805
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SODIUM ACETATE | sodium acetate | INJECTABLE;INJECTION | 214805 | ANDA | WOODWARD PHARMA SERVICES LLC | 69784-229 | 69784-229-10 | 10 VIAL, SINGLE-DOSE in 1 CASE (69784-229-10) / 20 mL in 1 VIAL, SINGLE-DOSE |
SODIUM ACETATE | sodium acetate | INJECTABLE;INJECTION | 214805 | ANDA | Woodward Pharma Services LLC | 69784-230 | 69784-230-10 | 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (69784-230-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MEQ/50ML (2MEQ/ML) | ||||
Approval Date: | May 4, 2021 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 4MEQ/ML | ||||
Approval Date: | Aug 25, 2023 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MEQ/100ML (2MEQ/ML) | ||||
Approval Date: | May 4, 2021 | TE: | AP | RLD: | No |
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