Details for New Drug Application (NDA): 208690
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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 208690
Tradename: | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE |
Applicant: | Amneal |
Ingredient: | dexamethasone sodium phosphate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208690
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 208690
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 208690 | ANDA | Amneal Pharmaceuticals LLC | 70121-1399 | 70121-1399-5 | 25 VIAL in 1 CARTON (70121-1399-5) / 1 mL in 1 VIAL (70121-1399-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG PHOSPHATE/ML | ||||
Approval Date: | Aug 22, 2018 | TE: | AP | RLD: | No |
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