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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040069

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NDA 040069 describes DEXAMETHASONE SODIUM PHOSPHATE, which is a drug marketed by Akorn, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Fresenius Kabi Usa, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, Teva Parenteral, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb, and Sandoz Inc, and is included in twenty-eight 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-one suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.

Summary for 040069

Pharmacology for NDA: 040069

Suppliers and Packaging for NDA: 040069

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate SOLUTION/DROPS;OPHTHALMIC, OTIC 040069 ANDA Major Pharmaceuticals 0904-3006 0904-3006-05 1 BOTTLE, DROPPER in 1 CARTON (0904-3006-05) > 5 mL in 1 BOTTLE, DROPPER
DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate SOLUTION/DROPS;OPHTHALMIC, OTIC 040069 ANDA Butler Animal Health Supply 11695-1411 11695-1411-2 1 BOTTLE, DROPPER in 1 CARTON (11695-1411-2) > 5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMIC, OTICStrengthEQ 0.1% PHOSPHATE
Approval Date:Jul 26, 1996TE:ATRLD:No


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