Details for New Drug Application (NDA): 075988

NDA 075988 describes PREDNISOLONE SODIUM PHOSPHATE, which is a drug marketed by Watson Labs, Alcon Pharms Ltd, Bausch And Lomb, Epic Pharma Llc, Sola Barnes Hind, Amneal, Amneal Pharms, Bausch, Chartwell Rx, Edenbridge Pharms, Endo Operations, Hikma, Mission Pharma, Nesher Pharms, Pharm Assoc, Pharmobedient, Pharmobedient Cnsltg, Vintage Pharms, We Pharms, and Rising, and is included in thirty NDAs. It is available from eleven 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. Fifteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.

Summary for 075988

Tradename:	PREDNISOLONE SODIUM PHOSPHATE
Applicant:	Chartwell Rx
Ingredient:	prednisolone sodium phosphate
Patents:	0

Pharmacology for NDA: 075988

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 075988

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	075988	ANDA	Chartwell RX, LLC.	62135-330	62135-330-24	2 TRAY in 1 BOX (62135-330-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-330-05)
PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	075988	ANDA	Chartwell RX, LLC.	62135-330	62135-330-41	120 mL in 1 BOTTLE (62135-330-41)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 5MG BASE/5ML
Approval Date:	May 25, 2004	TE:	AA	RLD:	No

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