Application 091093
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVETIRACETAM | LEVETIRACETAM | TABLET, EXTENDED RELEASE;ORAL | 500MG | No | No |
| 002 | LEVETIRACETAM | LEVETIRACETAM | TABLET, EXTENDED RELEASE;ORAL | 750MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-3635 | Levetiracetam | Levetiracetam | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3699 | Levetiracetam | Levetiracetam | Actavis Pharma, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 22722 | ORIG | 2012-06-22 |
| 31516 | ORIG | 2011-09-12 |