Details for New Drug Application (NDA): 207521
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NDA 207521 describes DEXAMETHASONE SODIUM PHOSPHATE, which is a drug marketed by Amneal, Bel Mar, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Geneyork Pharms, Gland, Hikma, Intl Medication, Luitpold, Lyphomed, Micro Labs, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb Inc, and Caplin, and is included in forty NDAs. It is available from twenty-four suppliers. Additional details are available on the DEXAMETHASONE SODIUM PHOSPHATE profile page.
The generic ingredient in DEXAMETHASONE SODIUM PHOSPHATE is dexamethasone sodium phosphate. There is one drug master file entry for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.
The generic ingredient in DEXAMETHASONE SODIUM PHOSPHATE is dexamethasone sodium phosphate. There is one drug master file entry for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.
Summary for 207521
| Tradename: | DEXAMETHASONE SODIUM PHOSPHATE |
| Applicant: | Somerset |
| Ingredient: | dexamethasone sodium phosphate |
| Patents: | 0 |
Pharmacology for NDA: 207521
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 207521
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 207521 | ANDA | Somerset Therapeutics, LLC | 70069-022 | 70069-022-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (70069-022-25) / 1 mL in 1 VIAL, SINGLE-DOSE (70069-022-01) |
| DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 207521 | ANDA | Somerset Therapeutics, LLC | 70069-023 | 70069-023-25 | 25 VIAL, MULTI-DOSE in 1 CARTON (70069-023-25) / 5 mL in 1 VIAL, MULTI-DOSE (70069-023-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 4MG PHOSPHATE/ML | ||||
| Approval Date: | Jun 8, 2018 | TE: | AP | RLD: | No | ||||
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