Details for New Drug Application (NDA): 040802
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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 040802
Tradename: | DEXAMETHASONE SODIUM PHOSPHATE |
Applicant: | Mylan Labs Ltd |
Ingredient: | dexamethasone sodium phosphate |
Patents: | 0 |
Pharmacology for NDA: 040802
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 040802
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 040802 | ANDA | Henry Schein, Inc. | 0404-9842 | 0404-9842-10 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9842-10) / 10 mL in 1 VIAL, MULTI-DOSE |
DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 040802 | ANDA | Mylan Institutional LLC | 67457-420 | 67457-420-10 | 10 VIAL in 1 CARTON (67457-420-10) / 10 mL in 1 VIAL (67457-420-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG PHOSPHATE/ML | ||||
Approval Date: | Aug 29, 2008 | TE: | AP | RLD: | No |
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