Application 206107
- Type
- ANDA
- Sponsor
- SIGMAPHARM LABS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ASENAPINE MALEATE | ASENAPINE MALEATE | TABLET;SUBLINGUAL | EQ 5MG BASE | No | No |
| 002 | ASENAPINE MALEATE | ASENAPINE MALEATE | TABLET;SUBLINGUAL | EQ 10MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42794-016 | ASENAPINE | ASENAPINE | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-016 | ASENAPINE | ASENAPINE | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-017 | ASENAPINE | ASENAPINE | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-017 | ASENAPINE | ASENAPINE | Sigmapharm Laboratories, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 55235 | ORIG | 2018-08-20 |