Details for New Drug Application (NDA): 214346
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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 214346
Tradename: | NYSTATIN |
Applicant: | Leading |
Ingredient: | nystatin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 214346
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NYSTATIN | nystatin | SUSPENSION;ORAL | 214346 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-3543 | 68071-3543-6 | 1 BOTTLE in 1 PACKAGE (68071-3543-6) / 60 mL in 1 BOTTLE |
NYSTATIN | nystatin | SUSPENSION;ORAL | 214346 | ANDA | Preferred Pharmaceuticals Inc. | 68788-8561 | 68788-8561-4 | 473 mL in 1 BOTTLE (68788-8561-4) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 100,000 UNITS/ML | ||||
Approval Date: | Mar 10, 2022 | TE: | AA | RLD: | No |
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