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Generated: September 20, 2018

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Details for New Drug Application (NDA): 081126

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NDA 081126 describes DEXAMETHASONE SODIUM PHOSPHATE, which is a drug marketed by Akorn, Amneal Pharms Co, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Fresenius Kabi Usa, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, 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-three NDAs. It is available from twenty-one 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-four suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.
Summary for 081126
Tradename:DEXAMETHASONE SODIUM PHOSPHATE
Applicant:Teva Parenteral
Ingredient:dexamethasone sodium phosphate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 10MG PHOSPHATE/ML
Approval Date:Aug 31, 1990TE:RLD:No

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