Details for New Drug Application (NDA): 062474
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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 062474
Tradename: | NYSTATIN |
Applicant: | Heritage Pharms |
Ingredient: | nystatin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 062474
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NYSTATIN | nystatin | TABLET;ORAL | 062474 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-051 | 23155-051-01 | 100 TABLET, COATED in 1 BOTTLE (23155-051-01) |
NYSTATIN | nystatin | TABLET;ORAL | 062474 | ANDA | Chartwell RX, LLC | 62135-741 | 62135-741-90 | 90 TABLET, FILM COATED in 1 BOTTLE (62135-741-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500,000 UNITS | ||||
Approval Date: | Dec 22, 1983 | TE: | AA | RLD: | No |
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