Details for New Drug Application (NDA): 064142
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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 064142
Tradename: | NYSTATIN |
Applicant: | Vistapharm |
Ingredient: | nystatin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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 | Cardinal Health 107, LLC | 55154-4056 | 55154-4056-5 | 5 CUP, UNIT-DOSE in 1 BAG (55154-4056-5) / 5 mL in 1 CUP, UNIT-DOSE |
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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