Skip to contentApplication 078956
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 25MG | No | No |
| 002 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 100MG | No | No |
| 003 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 150MG | No | No |
| 004 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-700 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-700 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-700 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-700 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-700 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-700 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-700 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-701 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-701 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-701 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-701 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-701 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-701 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-701 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-702 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-702 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-702 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-702 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-702 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-702 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-702 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-703 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-703 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-703 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-703 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-703 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-703 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-703 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 50090-3129 | Lamotrigine | Lamotrigine | A-S Medication Solutions | ANDA | Current |
| 65862-227 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-227 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-227 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-227 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-227 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-227 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-227 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-227 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-228 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-228 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-228 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-228 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-228 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-228 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-228 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-228 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-229 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-229 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-229 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-229 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-229 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-229 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-229 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-229 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-230 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-230 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-230 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-230 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-230 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-230 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-230 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-230 | Lamotrigine | Lamotrigine | Aurobindo Pharma Limited | ANDA | Current |
| 70518-3043 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-3109 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-3109 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-3139 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |