Details for New Drug Application (NDA): 215654
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NDA 215654 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 Pharma Ltd, 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, and Sandoz, and is included in forty NDAs. It is available from nineteen suppliers. Additional details are available on the DEXAMETHASONE SODIUM PHOSPHATE profile page.
The generic ingredient in DEXAMETHASONE SODIUM PHOSPHATE is dexamethasone sodium phosphate. There are thirty-nine drug master file entries for this compound. Twenty 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 are thirty-nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.
Summary for 215654
| Tradename: | DEXAMETHASONE SODIUM PHOSPHATE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | dexamethasone sodium phosphate |
| Patents: | 0 |
Pharmacology for NDA: 215654
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 215654
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 215654 | ANDA | Sagent Pharmaceuticals | 25021-052 | 25021-052-01 | 25 VIAL in 1 CARTON (25021-052-01) / 1 mL in 1 VIAL |
| DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 215654 | ANDA | Sagent Pharmaceuticals | 25021-052 | 25021-052-05 | 25 VIAL in 1 CARTON (25021-052-05) / 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 4MG PHOSPHATE/ML | ||||
| Approval Date: | Aug 4, 2021 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG PHOSPHATE/ML | ||||
| Approval Date: | Sep 25, 2023 | TE: | AP | RLD: | No | ||||
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