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Application 077319
- Type
- ANDA
- Sponsor
- OXFORD PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 250MG | No | No |
| 002 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 500MG | No | No |
| 003 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 750MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70518-0125 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-0126 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23867 | ORIG | 2009-04-14 |