Details for New Drug Application (NDA): 207521
✉ Email this page to a colleague
The generic ingredient in DEXAMETHASONE SODIUM PHOSPHATE is dexamethasone sodium phosphate. There are thirty-nine drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.
Summary for 207521
Tradename: | DEXAMETHASONE SODIUM PHOSPHATE |
Applicant: | Somerset |
Ingredient: | dexamethasone sodium phosphate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207521
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 207521
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 207521 | ANDA | Somerset Therapeutics, LLC | 70069-022 | 70069-022-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (70069-022-25) / 1 mL in 1 VIAL, SINGLE-DOSE (70069-022-01) |
DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 207521 | ANDA | Somerset Therapeutics, LLC | 70069-023 | 70069-023-25 | 25 VIAL, MULTI-DOSE in 1 CARTON (70069-023-25) / 5 mL in 1 VIAL, MULTI-DOSE (70069-023-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 4MG PHOSPHATE/ML | ||||
Approval Date: | Jun 8, 2018 | TE: | AP | RLD: | No |
Complete Access Available with Subscription