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Application 077644
- Type
- ANDA
- Sponsor
- UPSHER SMITH LABS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZONISAMIDE | ZONISAMIDE | CAPSULE;ORAL | 25MG | No | No |
| 002 | ZONISAMIDE | ZONISAMIDE | CAPSULE;ORAL | 50MG | No | No |
| 003 | ZONISAMIDE | ZONISAMIDE | CAPSULE;ORAL | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0185-0193 | Zonisamide | Zonisamide | Eon Labs, Inc. | ANDA | Current |
| 0185-0199 | Zonisamide | Zonisamide | Eon Labs, Inc. | ANDA | Current |
| 0185-0200 | Zonisamide | Zonisamide | Eon Labs, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 24163 | ORIG | 2008-02-01 |
| 31270 | ORIG | 2005-12-28 |