Details for New Drug Application (NDA): 209192
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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 209192
Tradename: | DEXAMETHASONE SODIUM PHOSPHATE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | dexamethasone sodium phosphate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209192
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 209192
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 209192 | ANDA | Fresenius Kabi USA, LLC | 76045-109 | 76045-109-10 | 24 BLISTER PACK in 1 CARTON (76045-109-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (76045-109-01) |
DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 209192 | ANDA | Fresenius Kabi USA, LLC | 76045-212 | 76045-212-10 | 24 BLISTER PACK in 1 CARTON (76045-212-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (76045-212-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG PHOSPHATE/ML | ||||
Approval Date: | Jul 6, 2018 | TE: | AP | RLD: | No |
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