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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 203621

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NDA 203621 describes NYSTATIN, which is a drug marketed by Actavis Mid Atlantic, Aurobindo Pharma, Chartwell Rx, Cosette, Crown Labs Inc, Fougera Pharms, Macleods Pharms Ltd, Padagis Us, Sun Pharma Canada, Torrent, Lyne, Zydus Lifesciences, Paddock Llc, Dr Reddys Labs Sa, Lupin, Nesher Pharms, Pharmobedient, Upsher Smith Labs, Zydus Pharms, Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs Inc, Genus, MLV, Morton Grove, Pai Holdings, Pharm Assoc, Pharmaderm, Pharmafair, Senores Pharms, Taro, Teva, Vistapharm Llc, Heritage, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Fougera, Odyssey Pharms, Alembic, Amneal, Glenmark Pharms Ltd, Lupin Ltd, Padagis Israel, Perrigo New York, Dr Reddys, Epic Pharma Llc, Pai Holdings Pharm, Rising, and Strides Pharma, and is included in ninety NDAs. It is available from thirty-nine suppliers. Additional details are available on the NYSTATIN profile page.

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

Summary for 203621

Tradename:	NYSTATIN
Applicant:	Pharm Assoc
Ingredient:	nystatin
Patents:	0

Pharmacology for NDA: 203621

Medical Subject Heading (MeSH) Categories for 203621

Anti-Bacterial Agents
Antifungal Agents
Ionophores

Suppliers and Packaging for NDA: 203621

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NYSTATIN	nystatin	SUSPENSION;ORAL	203621	ANDA	Pharmaceutical Associates, Inc.	0121-0810	0121-0810-02	60 mL in 1 BOTTLE, DROPPER (0121-0810-02)
NYSTATIN	nystatin	SUSPENSION;ORAL	203621	ANDA	Pharmaceutical Associates, Inc.	0121-0810	0121-0810-16	473 mL in 1 BOTTLE (0121-0810-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	100,000 UNITS/ML
Approval Date:	Jan 7, 2016	TE:	AA	RLD:	No

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