Details for New Drug Application (NDA): 091396

NDA 091396 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 091396

Tradename:	PREDNISOLONE SODIUM PHOSPHATE
Applicant:	Mission Pharma
Ingredient:	prednisolone sodium phosphate
Patents:	0

Pharmacology for NDA: 091396

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 091396

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	091396	ANDA	BioComp Pharma, Inc.	44523-182	44523-182-08	237 mL in 1 BOTTLE (44523-182-08)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 25MG BASE/5ML
Approval Date:	Sep 13, 2010	TE:	AA	RLD:	No

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