Details for New Drug Application (NDA): 208581
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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 208581
Tradename: | NYSTATIN |
Applicant: | Zydus Pharms |
Ingredient: | nystatin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 208581
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NYSTATIN | nystatin | POWDER;TOPICAL | 208581 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-2621 | 68071-2621-6 | 60 g in 1 BOTTLE, PLASTIC (68071-2621-6) |
NYSTATIN | nystatin | POWDER;TOPICAL | 208581 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-370 | 68382-370-01 | 15 g in 1 BOTTLE, PLASTIC (68382-370-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;TOPICAL | Strength | 100,000 UNITS/GM | ||||
Approval Date: | Jun 8, 2017 | TE: | AT | RLD: | No |
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