Details for New Drug Application (NDA): 210532
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NDA 210532 describes KLAYESTA, which is a drug marketed by Epic Pharma Llc and is included in one NDA. It is available from one supplier. Additional details are available on the KLAYESTA profile page.
The generic ingredient in KLAYESTA is nystatin. There are eight drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the nystatin profile page.
The generic ingredient in KLAYESTA is nystatin. There are eight drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the nystatin profile page.
Summary for 210532
| Tradename: | KLAYESTA |
| Applicant: | Epic Pharma Llc |
| Ingredient: | nystatin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210532
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KLAYESTA | nystatin | POWDER;TOPICAL | 210532 | ANDA | Epic Pharma, LLC | 42806-178 | 42806-178-15 | 15 g in 1 BOTTLE (42806-178-15) |
| KLAYESTA | nystatin | POWDER;TOPICAL | 210532 | ANDA | Epic Pharma, LLC | 42806-178 | 42806-178-30 | 30 g in 1 BOTTLE (42806-178-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;TOPICAL | Strength | 100,000 UNITS/GM | ||||
| Approval Date: | Apr 30, 2018 | TE: | AT | RLD: | No | ||||
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