Details for New Drug Application (NDA): 064118
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NDA 064118 describes NYSTOP, which is a drug marketed by Padagis Us and is included in one NDA. It is available from three suppliers. Additional details are available on the NYSTOP profile page.
The generic ingredient in NYSTOP is nystatin. There are eight drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the nystatin profile page.
The generic ingredient in NYSTOP is nystatin. There are eight drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the nystatin profile page.
Summary for 064118
| Tradename: | NYSTOP |
| Applicant: | Padagis Us |
| Ingredient: | nystatin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 064118
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NYSTOP | nystatin | POWDER;TOPICAL | 064118 | ANDA | Padagis US LLC | 0574-2008 | 0574-2008-02 | 60 g in 1 BOTTLE, PLASTIC (0574-2008-02) |
| NYSTOP | nystatin | POWDER;TOPICAL | 064118 | ANDA | Padagis US LLC | 0574-2008 | 0574-2008-15 | 15 g in 1 BOTTLE, PLASTIC (0574-2008-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;TOPICAL | Strength | 100,000 UNITS/GM | ||||
| Approval Date: | Aug 16, 1996 | TE: | AT | RLD: | No | ||||
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