Details for New Drug Application (NDA): 064142
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NDA 064142 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, Adrastea Pharma, Dr Reddys Labs Sa, Epic Pharma Llc, Lupin, Nesher Pharms, Upsher Smith Labs, Zydus Pharms, Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs Inc, Genus, Leading, MLV, Morton Grove, Pai Holdings, Pharm Assoc, Pharmaderm, Pharmafair, Teva, Vistapharm, Wockhardt Bio Ag, Chartwell Rx, Heritage, 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 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-one suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
The generic ingredient in NYSTATIN is nystatin; triamcinolone acetonide. There are eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
Summary for 064142
| Tradename: | NYSTATIN |
| Applicant: | Vistapharm |
| Ingredient: | nystatin |
| Patents: | 0 |
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 | ATLANTIC BIOLOGICALS CORP. | 17856-1008 | 17856-1008-1 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-1008-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-1008-2) |
| NYSTATIN | nystatin | SUSPENSION;ORAL | 064142 | ANDA | Bryant Ranch Prepack | 63629-8519 | 63629-8519-1 | 480 mL in 1 BOTTLE (63629-8519-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION;ORAL | Strength | 100,000 UNITS/ML | ||||
| Approval Date: | Jun 25, 1998 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION;ORAL | Strength | 100,000 UNITS/ML | ||||
| Approval Date: | Mar 7, 2011 | TE: | RLD: | No | |||||
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