Details for New Drug Application (NDA): 084916
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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 084916
Tradename: | DEXAMETHASONE SODIUM PHOSPHATE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | dexamethasone sodium phosphate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 084916
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 084916
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 084916 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1370 | 51662-1370-1 | 5 mL in 1 VIAL, MULTI-DOSE (51662-1370-1) |
DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 084916 | ANDA | Cardinal Health 107, LLC | 55154-9364 | 55154-9364-5 | 5 VIAL in 1 BAG (55154-9364-5) / 1 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 4MG PHOSPHATE/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes |
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