Details for New Drug Application (NDA): 211036
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The generic ingredient in DEXAMETHASONE SODIUM PHOSPHATE is dexamethasone sodium phosphate. There are thirty-nine drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.
Summary for 211036
Tradename: | DEXAMETHASONE SODIUM PHOSPHATE |
Applicant: | Somerset Theraps Llc |
Ingredient: | dexamethasone sodium phosphate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211036
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 211036
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 211036 | ANDA | Somerset Therapeutics, LLC | 70069-025 | 70069-025-10 | 10 VIAL in 1 CARTON (70069-025-10) / 10 mL in 1 VIAL |
DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 211036 | ANDA | Medical Purchasing Solutions, LLC | 71872-7205 | 71872-7205-1 | 1 VIAL in 1 BAG (71872-7205-1) / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG PHOSPHATE/ML | ||||
Approval Date: | May 10, 2019 | TE: | AP | RLD: | No |
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