Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075183

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NDA 075183 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 fifteen 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-eight drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
Summary for 075183
Tradename:PREDNISOLONE SODIUM PHOSPHATE
Applicant:Hi Tech Pharma
Ingredient:prednisolone sodium phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075183
Suppliers and Packaging for NDA: 075183
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 075183 ANDA A-S Medication Solutions 50090-1411 50090-1411-0 120 mL in 1 BOTTLE (50090-1411-0)
PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 075183 ANDA Hi-Tech Pharmacal Co., Inc. 50383-040 50383-040-04 120 mL in 1 BOTTLE (50383-040-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 5MG BASE/5ML
Approval Date:Mar 26, 2003TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Harvard Business School
McKinsey
Baxter
Dow

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