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Generated: July 28, 2017

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Details for New Drug Application (NDA): 202179

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NDA 202179 describes PREDNISOLONE SODIUM PHOSPHATE, which is a drug marketed by Vintage, Pharm Assoc, Vintage Pharms, Watson Labs, Alcon Pharms Ltd, Amneal Pharms, Medicis Pharms, Akorn, Edenbridge Pharms, Bausch And Lomb, Sola Barnes Hind, Mylan Pharms Inc, We Pharms, Nesher Pharms, Hi Tech Pharma, Chartwell Rx, Wockhardt, and Mission Pharma, and is included in twenty-eight NDAs. It is available from twenty-one 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.

Summary for NDA: 202179

Tradename:	1
Applicant:	1
Ingredient:	1
Patents:	0
Therapeutic Class:	Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal) Inflammatory Bowel Disease Agents Ophthalmic Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 202179

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 202179

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	202179	ANDA	Mylan Pharmaceuticals Inc.	0378-4710	0378-4710-22	48 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-4710-22)
PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	202179	ANDA	Mylan Pharmaceuticals Inc.	0378-4715	0378-4715-22	48 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-4715-22)

Summary for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	EQ 10MG BASE
Approval Date:	Apr 10, 2013	TE:	AB	RLD:	No

Summary for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	EQ 15MG BASE
Approval Date:	Apr 10, 2013	TE:	AB	RLD:	No

Summary for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	EQ 30MG BASE
Approval Date:	Apr 10, 2013	TE:	AB	RLD:	No

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