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Last Updated: August 4, 2020

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Details for New Drug Application (NDA): 208689

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NDA 208689 describes DEXAMETHASONE SODIUM PHOSPHATE, which is a drug marketed by Akorn, Amneal, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Dr Reddys, Fresenius Kabi Usa, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb, and Sandoz Inc, and is included in thirty-five NDAs. It is available from seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.
Summary for 208689
Tradename:DEXAMETHASONE SODIUM PHOSPHATE
Applicant:Amneal
Ingredient:dexamethasone sodium phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208689
Suppliers and Packaging for NDA: 208689
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 208689 ANDA Amneal Pharmaceuticals LLC 70121-1450 70121-1450-5 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1450-5) > 1 mL in 1 VIAL, SINGLE-DOSE (70121-1450-1)
DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 208689 ANDA Amneal Pharmaceuticals LLC 70121-1451 70121-1451-5 25 VIAL, MULTI-DOSE in 1 CARTON (70121-1451-5) > 5 mL in 1 VIAL, MULTI-DOSE (70121-1451-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4MG PHOSPHATE/ML
Approval Date:Aug 22, 2018TE:APRLD:No

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