BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Fuji
US Department of Justice
McKesson
Deloitte
Chinese Patent Office
Daiichi Sankyo
Federal Trade Commission
US Army
Citi
Mallinckrodt

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078465

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NDA 078465 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, 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-three suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
Pharmacology for NDA: 078465
Suppliers and Packaging for NDA: 078465
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 078465 ANDA Pharmaceutical Associates, Inc. 0121-0773 0121-0773-08 237 mL in 1 BOTTLE (0121-0773-08)
PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 078465 ANDA Zylera Pharmaceuticals, LLC 23594-510 23594-510-08 237 mL in 1 BOTTLE (23594-510-08)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 10MG BASE/5ML
Approval Date:Mar 7, 2008TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Teva
Chubb
Cipla
Federal Trade Commission
Fuji
Harvard Business School
Cantor Fitzgerald
Covington
Deloitte

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