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Generated: April 28, 2017

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Details for New Drug Application (NDA): 087702

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NDA 087702 describes DEXAMETHASONE SODIUM PHOSPHATE, which is a drug marketed by Mylan Labs Ltd, Watson Labs, West-ward Pharms Int, Fresenius Kabi Usa, Intl Medication, Teva Parenteral, Luitpold, Wyeth Ayerst, Bel Mar, Akorn, Dell Labs, Lyphomed, Bausch And Lomb, Sola Barnes Hind, Sandoz Inc, and Aurobindo Pharma Ltd, and is included in twenty-eight 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-three suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.

Summary for NDA: 087702

Pharmacology for NDA: 087702

Suppliers and Packaging for NDA: 087702

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate
INJECTABLE;INJECTION 087702 ANDA West-Ward Pharmaceuticals Corp. 0641-0367 0641-0367-25 25 VIAL in 1 CARTON (0641-0367-25) > 1 mL in 1 VIAL (0641-0367-21)
DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate
INJECTABLE;INJECTION 087702 ANDA Terrain Pharmaceuticals 53225-3660 53225-3660-1 1 mL in 1 VIAL (53225-3660-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG PHOSPHATE/ML
Approval Date:Sep 7, 1982TE:APRLD:No


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