Application 079063
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVETIRACETAM | LEVETIRACETAM | SOLUTION;ORAL | 100MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-358 | Levetiracetam | Levetiracetam | NorthStar Rx LLC | ANDA | Current |
| 16714-358 | Levetiracetam | Levetiracetam | NorthStar Rx LLC | ANDA | Current |
| 16714-358 | Levetiracetam | Levetiracetam | NorthStar Rx LLC | ANDA | Current |
| 16714-358 | Levetiracetam | Levetiracetam | NorthStar Rx LLC | ANDA | Current |
| 16714-358 | Levetiracetam | Levetiracetam | NorthStar Rx LLC | ANDA | Current |
| 63739-019 | LEVETIRACETAM | levetiracetam | McKesson Corporation DBA SKY Packaging | ANDA | Current |
| 63739-019 | Levetiracetam | Levetiracetam | McKesson Corporation | ANDA | Current |
| 63739-019 | Levetiracetam | Levetiracetam | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 65862-250 | Levetiracetam | Levetiracetam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-250 | Levetiracetam | Levetiracetam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-250 | Levetiracetam | Levetiracetam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-250 | Levetiracetam | Levetiracetam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-250 | Levetiracetam | Levetiracetam | Aurobindo Pharma Limited | ANDA | Current |
| 70518-3582 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9215 | ORIG | 2009-01-21 |