Details for New Drug Application (NDA): 207442
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NDA 207442 describes DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE, which is a drug marketed by Amneal, Fresenius Kabi Usa, and Somerset Theraps Llc, and is included in three NDAs. It is available from four suppliers. Additional details are available on the DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE profile page.
The generic ingredient in DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE 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.
The generic ingredient in DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE 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 207442
| Tradename: | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | dexamethasone sodium phosphate |
| Patents: | 0 |
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 | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0261 | 80425-0261-1 | 25 VIAL in 1 CARTON (80425-0261-1) / 1 mL in 1 VIAL |
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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