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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 062838


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NDA 062838 describes NYSTATIN, which is a drug marketed by Actavis Mid Atlantic, Cosette, Crown Labs Inc, Fougera Pharms, Macleods Pharms Ltd, Padagis Us, Strides Pharma, Taro, Torrent, Lyne, Zydus Lifesciences, Paddock Llc, Beowulf Asset, Dr Reddys Labs Sa, Epic Pharma Llc, Lupin, Nesher Pharms, Upsher Smith Labs, Zydus Pharms, Akorn, Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs Inc, Genus, Leading, MLV, Morton Grove, Pharm Assoc, Pharmaderm, Pharmafair, Teva, Vistapharm, Wockhardt Bio Ag, Chartwell Rx, Heritage Pharms, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Fougera, Odyssey Pharms, Alembic, Amneal, Dr Reddys, Glenmark Pharms Ltd, Lupin Ltd, Padagis Israel, Perrigo New York, Pai Holdings Pharm, and Rising, and is included in ninety NDAs. It is available from forty-three 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. Twenty-two suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
Summary for 062838
Tradename:NYSTATIN
Applicant:Sun Pharm Industries
Ingredient:nystatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 062838
Medical Subject Heading (MeSH) Categories for 062838
Suppliers and Packaging for NDA: 062838
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN nystatin TABLET;ORAL 062838 ANDA Sun Pharmaceutical Industries, Inc. 53489-400 53489-400-01 100 TABLET, FILM COATED in 1 BOTTLE (53489-400-01)
NYSTATIN nystatin TABLET;ORAL 062838 ANDA Sun Pharmaceutical Industries, Inc. 53489-400 53489-400-02 50 TABLET, FILM COATED in 1 BOTTLE (53489-400-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500,000 UNITS
Approval Date:Dec 22, 1988TE:AARLD:No

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