Application 080198
- Type
- ANDA
- Sponsor
- FOUGERA PHARMS INC
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LIDOCAINE | LIDOCAINE | OINTMENT;TOPICAL | 5% | No | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0168-0204 | Lidocaine | Lidocaine | Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0204 | Lidocaine | Lidocaine | Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0204 | Lidocaine | Lidocaine | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 21695-826 | Lidocaine | Lidocaine | Rebel Distributors Corp | ANDA | Current |
| 33261-564 | Lidocaine | Lidocaine | Aidarex Pharmaceuticals LLC | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 43159 | SUPPL | 2015-03-11 |