Details for New Drug Application (NDA): 214181

NDA 214181 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-two 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-two suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

Summary for 214181

Tradename:	NYSTATIN AND TRIAMCINOLONE ACETONIDE
Applicant:	Macleods Pharms Ltd
Ingredient:	nystatin; triamcinolone acetonide
Patents:	0

Pharmacology for NDA: 214181

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 214181

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin; triamcinolone acetonide	CREAM;TOPICAL	214181	ANDA	Macleods Pharmaceuticals Limited	33342-482	33342-482-15	1 TUBE in 1 CARTON (33342-482-15) / 15 g in 1 TUBE
NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin; triamcinolone acetonide	CREAM;TOPICAL	214181	ANDA	Macleods Pharmaceuticals Limited	33342-482	33342-482-30	1 TUBE in 1 CARTON (33342-482-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	100,000 UNITS/GM;0.1%
Approval Date:	Jul 13, 2022	TE:	AT	RLD:	No

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