Asenapine is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is Asenapine Maleate.
Product ID | 51991-361_2dad5276-94e7-4dad-aa34-ae5513d49c1b |
NDC | 51991-361 |
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 | Breckenridge Pharmaceutical, Inc. |
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 | 2020-12-10 |
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 |