Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206107
Company: SIGMAPHARM LABS LLC
Company: SIGMAPHARM LABS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ASENAPINE MALEATE | ASENAPINE MALEATE | EQ 5MG BASE | TABLET;SUBLINGUAL | Prescription | AB | No | No |
ASENAPINE MALEATE | ASENAPINE MALEATE | EQ 10MG BASE | TABLET;SUBLINGUAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/10/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206107Orig1s000ltr.pdf |
ASENAPINE MALEATE
TABLET;SUBLINGUAL; EQ 5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ASENAPINE MALEATE | ASENAPINE MALEATE | EQ 5MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 206098 | ALEMBIC |
ASENAPINE MALEATE | ASENAPINE MALEATE | EQ 5MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 205960 | BRECKENRIDGE |
ASENAPINE MALEATE | ASENAPINE MALEATE | EQ 5MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 206107 | SIGMAPHARM LABS LLC |
SAPHRIS | ASENAPINE MALEATE | EQ 5MG BASE | TABLET;SUBLINGUAL | Prescription | Yes | AB | 022117 | ALLERGAN |
TABLET;SUBLINGUAL; EQ 10MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ASENAPINE MALEATE | ASENAPINE MALEATE | EQ 10MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 206098 | ALEMBIC |
ASENAPINE MALEATE | ASENAPINE MALEATE | EQ 10MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 205960 | BRECKENRIDGE |
ASENAPINE MALEATE | ASENAPINE MALEATE | EQ 10MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 206107 | SIGMAPHARM LABS LLC |
SAPHRIS | ASENAPINE MALEATE | EQ 10MG BASE | TABLET;SUBLINGUAL | Prescription | Yes | AB | 022117 | ALLERGAN |