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Last Updated: April 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064142

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NDA 064142 describes NYSTATIN, which is a drug marketed by Acp Nimble, Actavis Mid Atlantic, Crown Labs Inc, Fougera Pharms, Perrigo New York, Taro, Torrent, Vintage, Cadila, Lyne, Paddock Llc, Epic Pharma Llc, Lupin, Mayne Pharma Inc, Nesher Pharms, Upsher Smith Labs, Xgen Pharms, Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs Inc, Hi Tech Pharma, Lannett Co Inc, Morton Grove, Pharm Assoc, Pharmaderm, Pharmafair, Socorro, Teva, Vistapharm, Wockhardt Bio Ag, Heritage Pharms Inc, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Fougera, Odyssey Pharms, Amneal Pharms Llc, Dr Reddys, Glenmark Pharms Ltd, Lupin Ltd, Perrigo Uk Finco, Akorn, Rising, Strides Pharma, Teligent Pharma Inc, Vitruvias Therap, and Zydus Pharms, and is included in eighty-three NDAs. It is available from forty 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. Nineteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
Summary for 064142
Formulation / Manufacturing:see details
Pharmacology for NDA: 064142
Medical Subject Heading (MeSH) Categories for 064142
Suppliers and Packaging for NDA: 064142
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN nystatin SUSPENSION;ORAL 064142 ANDA Cardinal Health 55154-4056 55154-4056-5 5 CUP, UNIT-DOSE in 1 BAG (55154-4056-5) > 5 mL in 1 CUP, UNIT-DOSE
NYSTATIN nystatin SUSPENSION;ORAL 064142 ANDA Cardinal Health 55154-4059 55154-4059-5 5 CUP, UNIT-DOSE in 1 BAG (55154-4059-5) > 5 mL in 1 CUP, UNIT-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength100,000 UNITS/ML
Approval Date:Jun 25, 1998TE:AARLD:No

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