Asenapine is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Msn Laboratories Private Limited. The primary component is Asenapine Maleate.
| Product ID | 69539-059_0b3bd9c9-493d-4c79-ac97-b9bbfbd4ec2e |
| NDC | 69539-059 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Asenapine |
| Generic Name | Asenapine Maleate |
| Dosage Form | Tablet |
| Route of Administration | SUBLINGUAL |
| Marketing Start Date | 2020-12-10 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA205960 |
| Labeler Name | MSN LABORATORIES PRIVATE LIMITED |
| Substance Name | ASENAPINE MALEATE |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Atypical Antipsychotic [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2021-08-27 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 42794-016 | ASENAPINE | ASENAPINE |
| 42794-017 | ASENAPINE | ASENAPINE |
| 46708-198 | Asenapine | Asenapine |
| 46708-199 | Asenapine | Asenapine |
| 46708-544 | Asenapine | Asenapine |
| 51991-358 | Asenapine | ASENAPINE MALEATE |
| 51991-359 | Asenapine | ASENAPINE MALEATE |
| 51991-360 | Asenapine | ASENAPINE MALEATE |
| 51991-361 | Asenapine | ASENAPINE MALEATE |
| 51991-928 | Asenapine | ASENAPINE MALEATE |
| 59762-1091 | Asenapine | asenapine maleate |
| 59762-2012 | Asenapine | asenapine maleate |
| 59762-2888 | Asenapine | asenapine maleate |
| 62332-198 | Asenapine | Asenapine |
| 69539-059 | Asenapine | Asenapine |
| 62332-199 | Asenapine | Asenapine |
| 0052-0118 | SAPHRIS | Asenapine Maleate |
| 0052-0119 | SAPHRIS | Asenapine Maleate |
| 0052-2139 | SAPHRIS | Asenapine Maleate |
| 0052-2142 | SAPHRIS | Asenapine Maleate |
| 0456-2402 | SAPHRIS | Asenapine Maleate |
| 0456-2405 | SAPHRIS | Asenapine Maleate |
| 0456-2410 | SAPHRIS | Asenapine Maleate |