Application 206098
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ASENAPINE | ASENAPINE | TABLET;SUBLINGUAL | 5MG | No | No |
| 002 | ASENAPINE | ASENAPINE | TABLET;SUBLINGUAL | 10MG | No | No |
| 003 | ASENAPINE MALEATE | ASENAPINE MALEATE | TABLET;SUBLINGUAL | EQ 2.5MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-198 | Asenapine | Asenapine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-198 | Asenapine | Asenapine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-199 | Asenapine | Asenapine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-199 | Asenapine | Asenapine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-544 | Asenapine | Asenapine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-198 | Asenapine | Asenapine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-198 | Asenapine | Asenapine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-198 | Asenapine | Asenapine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-199 | Asenapine | Asenapine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-199 | Asenapine | Asenapine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-199 | Asenapine | Asenapine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-544 | Asenapine | Asenapine | Alembic Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 49687 | ORIG | 2017-09-07 |