Details for New Drug Application (NDA): 207767
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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 207767
Tradename: | NYSTATIN |
Applicant: | Zydus Lifesciences |
Ingredient: | nystatin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207767
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NYSTATIN | nystatin | OINTMENT;TOPICAL | 207767 | ANDA | A-S Medication Solutions | 50090-5845 | 50090-5845-0 | 15 g in 1 TUBE (50090-5845-0) |
NYSTATIN | nystatin | OINTMENT;TOPICAL | 207767 | ANDA | Bryant Ranch Prepack | 63629-2515 | 63629-2515-1 | 30 g in 1 TUBE (63629-2515-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 100,000 UNITS/GM | ||||
Approval Date: | May 25, 2018 | TE: | AT | RLD: | No |
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