Application 076708
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
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 |
|---|
| 55111-220 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-220 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-221 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-221 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-222 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-222 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-223 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-223 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 63739-448 | Lamotrigine | Lamotrigine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-448 | Lamotrigine | Lamotrigine | McKesson Corporation | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 43099 | ORIG | 2012-02-14 |