U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206098
Company: ALEMBIC PHARMS LTD
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
ASENAPINE MALEATE ASENAPINE MALEATE EQ 2.5MG 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/2020/206098Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/19/2021 SUPPL-2 Labeling-Container/Carton Labels

Label is not available on this site.

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 PHARMS LTD
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 PHARMS LTD
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

TABLET;SUBLINGUAL; EQ 2.5MG 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 2.5MG BASE TABLET;SUBLINGUAL Prescription No AB 206098 ALEMBIC PHARMS LTD
ASENAPINE MALEATE ASENAPINE MALEATE EQ 2.5MG BASE TABLET;SUBLINGUAL Prescription No AB 205960 BRECKENRIDGE
SAPHRIS ASENAPINE MALEATE EQ 2.5MG BASE TABLET;SUBLINGUAL Prescription Yes AB 022117 ALLERGAN
Back to Top