Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205689
Company: SUN PHARM
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
11/16/2017 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 205430 APOTEX INC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202578 MYLAN
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202568 SANDOZ INC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205689 SUN PHARM
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
INTUNIV GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022037 SHIRE

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 205430 APOTEX INC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202578 MYLAN
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202568 SANDOZ INC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205689 SUN PHARM
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
INTUNIV GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022037 SHIRE

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 205430 APOTEX INC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202578 MYLAN
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202568 SANDOZ INC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205689 SUN PHARM
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
INTUNIV GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022037 SHIRE

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 205430 APOTEX INC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202578 MYLAN
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202568 SANDOZ INC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205689 SUN PHARM
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
INTUNIV GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022037 SHIRE

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