Details for New Drug Application (NDA): 210077

NDA 210077 describes NYSTATIN AND TRIAMCINOLONE ACETONIDE, which is a drug marketed by Alembic, Alpharma Us Pharms, Amneal, Crown Labs Inc, Dr Reddys, Fougera Pharms Inc, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Padagis Israel, Perrigo New York, Pharmafair, Taro, Torrent, Chartwell Rx, Epic Pharma Llc, Pai Holdings Pharm, Rising, Strides Pharma, and Zydus Lifesciences, and is included in thirty-one NDAs. It is available from twenty-one suppliers. Additional details are available on the NYSTATIN AND TRIAMCINOLONE ACETONIDE profile page.

The generic ingredient in NYSTATIN AND TRIAMCINOLONE ACETONIDE is nystatin; triamcinolone acetonide. There are eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

Summary for 210077

Tradename:	NYSTATIN AND TRIAMCINOLONE ACETONIDE
Applicant:	Strides Pharma
Ingredient:	nystatin; triamcinolone acetonide
Patents:	0

Pharmacology for NDA: 210077

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 210077

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin; triamcinolone acetonide	OINTMENT;TOPICAL	210077	ANDA	Strides Pharma Science Limited	64380-836	64380-836-22	1 TUBE in 1 CARTON (64380-836-22) / 15 g in 1 TUBE
NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin; triamcinolone acetonide	OINTMENT;TOPICAL	210077	ANDA	Strides Pharma Science Limited	64380-836	64380-836-23	1 TUBE in 1 CARTON (64380-836-23) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	100,000 UNITS/GM;0.1%
Approval Date:	Jan 29, 2018	TE:	AT	RLD:	No

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