U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 217269
Company: ALEMBIC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL 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
08/07/2023 ORIG-1 Approval STANDARD

Label is not available on this site.

GUANFACINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200881 ACTAVIS ELIZABETH
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 217269 ALEMBIC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205430 APOTEX
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 217638 FOSUN WANBANG
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 219689 RUBICON RESEARCH
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202568 SANDOZ
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201382 TEVA PHARMS USA
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201408 TWI PHARMS
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 219033 UNICHEM
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213428 YICHANG HUMANWELL
INTUNIV GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022037 TAKEDA PHARMS USA

TABLET, EXTENDED RELEASE;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200881 ACTAVIS ELIZABETH
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 217269 ALEMBIC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205430 APOTEX
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 217638 FOSUN WANBANG
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 219689 RUBICON RESEARCH
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202568 SANDOZ
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201382 TEVA PHARMS USA
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201408 TWI PHARMS
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 219033 UNICHEM
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213428 YICHANG HUMANWELL
INTUNIV GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022037 TAKEDA PHARMS USA

TABLET, EXTENDED RELEASE;ORAL; EQ 3MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200881 ACTAVIS ELIZABETH
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 217269 ALEMBIC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205430 APOTEX
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 217638 FOSUN WANBANG
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 219689 RUBICON RESEARCH
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202568 SANDOZ
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201382 TEVA PHARMS USA
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201408 TWI PHARMS
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 219033 UNICHEM
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213428 YICHANG HUMANWELL
INTUNIV GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022037 TAKEDA PHARMS USA

TABLET, EXTENDED RELEASE;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200881 ACTAVIS ELIZABETH
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 217269 ALEMBIC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205430 APOTEX
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 217638 FOSUN WANBANG
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 219689 RUBICON RESEARCH
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202568 SANDOZ
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201382 TEVA PHARMS USA
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201408 TWI PHARMS
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 219033 UNICHEM
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213428 YICHANG HUMANWELL
INTUNIV GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022037 TAKEDA PHARMS USA
Back to Top