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Application 078625
- Type
- ANDA
- Sponsor
- RUBICON
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 |
|---|
| 70518-3602 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 72888-025 | Lamotrigine | Lamotrigine | Advagen Pharma Limited | ANDA | Current |
| 72888-025 | Lamotrigine | Lamotrigine | Advagen Pharma Limited | ANDA | Current |
| 72888-026 | Lamotrigine | Lamotrigine | Advagen Pharma Limited | ANDA | Current |
| 72888-026 | Lamotrigine | Lamotrigine | Advagen Pharma Limited | ANDA | Current |
| 72888-027 | Lamotrigine | Lamotrigine | Advagen Pharma Limited | ANDA | Current |
| 72888-027 | Lamotrigine | Lamotrigine | Advagen Pharma Limited | ANDA | Current |
| 72888-028 | Lamotrigine | Lamotrigine | Advagen Pharma Limited | ANDA | Current |
| 72888-028 | Lamotrigine | Lamotrigine | Advagen Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9174 | ORIG | 2012-02-14 |