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Johnson and Johnson
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Medtronic
Baxter
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Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078345

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NDA 078345 describes PREDNISOLONE SODIUM PHOSPHATE, which is a drug marketed by Watson Labs, Akorn, Alcon Pharms Ltd, Bausch And Lomb, Sola Barnes Hind, Amneal Pharms, Chartwell Rx, Edenbridge Pharms, Hi Tech Pharma, Medicis Pharms, Mission Pharma, Nesher Pharms, Pharm Assoc, Vintage, Vintage Pharms, We Pharms, Wockhardt Bio Ag, and Mylan Pharms Inc, and is included in twenty-eight NDAs. It is available from twenty suppliers. Additional details are available on the PREDNISOLONE SODIUM PHOSPHATE profile page.

The generic ingredient in PREDNISOLONE SODIUM PHOSPHATE is prednisolone sodium phosphate. There are eighty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
Pharmacology for NDA: 078345
Suppliers and Packaging for NDA: 078345
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 078345 ANDA Rebel Distributors Corp 42254-102 E 42254-102-08
PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 078345 ANDA Amneal Pharmaceuticals of New York, LLC 65162-667 N 65162-667-76

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrengthEQ 15MG BASE/5ML
Approval Date:Mar 10, 2009TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
US Department of Justice
Merck
Farmers Insurance
UBS
Cantor Fitzgerald
Covington
Chinese Patent Office
Argus Health

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