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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202568
Company: SANDOZ

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
06/03/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202568Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/29/2020 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
07/30/2019 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
07/30/2019 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert

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
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