Details for New Drug Application (NDA): 208689
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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. Nineteen suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.
Summary for 208689
Tradename: | DEXAMETHASONE SODIUM PHOSPHATE |
Applicant: | Amneal |
Ingredient: | dexamethasone sodium phosphate |
Patents: | 0 |
Pharmacology for NDA: 208689
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 208689
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 208689 | ANDA | Amneal Pharmaceuticals LLC | 70121-1450 | 70121-1450-5 | 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1450-5) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1450-1) |
DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 208689 | ANDA | Amneal Pharmaceuticals LLC | 70121-1451 | 70121-1451-5 | 25 VIAL, MULTI-DOSE in 1 CARTON (70121-1451-5) / 5 mL in 1 VIAL, MULTI-DOSE (70121-1451-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 4MG PHOSPHATE/ML | ||||
Approval Date: | Aug 22, 2018 | TE: | AP | RLD: | No |
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