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Details for New Drug Application (NDA): 064042

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NDA 064042 describes NYSTATIN, which is a drug marketed by Watson Labs, Teva, Mayne Pharma Inc, Quantum Pharmics, Wockhardt, Paddock Llc, Vintage, Odyssey Pharms, Fougera, Pharmaderm, Nesher Pharms, Pharm Assoc, Taro, Vistapharm, Fougera Pharms, Usl Pharma, Perrigo New York, Roxane, Morton Grove, Gavis Pharms, Sun Pharm Inds, Actavis Mid Atlantic, Pharmafair, Hi Tech Pharma, Vintage Pharms, G And W Labs Inc, Sandoz, Alpharma Us Pharms, Heritage Pharms Inc, X Gen Pharms, Upsher Smith, and Glenmark Pharms Ltd, and is included in fifty-nine NDAs. It is available from forty-seven 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. Twelve suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

Summary for NDA: 064042

Hi Tech Pharma
Therapeutic Class:Antifungals

Pharmacology for NDA: 064042


Suppliers and Packaging for NDA: 064042

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSPENSION;ORAL 064042 ANDA Rebel Distributors Corp 42254-322 42254-322-60 1 BOTTLE, DROPPER in 1 CARTON (42254-322-60) > 60 mL in 1 BOTTLE, DROPPER
SUSPENSION;ORAL 064042 ANDA Hi-Tech Pharmacal Co., Inc. 50383-587 50383-587-16 473 mL in 1 BOTTLE (50383-587-16)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength100,000 UNITS/ML
Approval Date:Feb 28, 1994TE:AARLD:No

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