Details for New Drug Application (NDA): 207442
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The generic ingredient in DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE 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 207442
Tradename: | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE |
Applicant: | Somerset Theraps Llc |
Ingredient: | dexamethasone sodium phosphate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207442
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 207442
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 207442 | ANDA | Somerset Therapeutics, LLC | 70069-021 | 70069-021-25 | 25 VIAL in 1 CARTON (70069-021-25) / 1 mL in 1 VIAL (70069-021-01) |
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 207442 | ANDA | REMEDYREPACK INC. | 70518-1922 | 70518-1922-1 | 25 VIAL in 1 CARTON (70518-1922-1) / 1 mL in 1 VIAL (70518-1922-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG PHOSPHATE/ML | ||||
Approval Date: | Apr 19, 2018 | TE: | AP | RLD: | No |
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