Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074796
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription AB No Yes
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/27/1997 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/22/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

07/16/2003 SUPPL-3 Labeling

Label is not available on this site.

12/12/2002 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/23/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

GUANFACINE HYDROCHLORIDE

TABLET;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;ORAL Prescription No AB 075109 AMNEAL PHARM
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 074796 MYLAN
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 074145 WATSON LABS

TABLET;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;ORAL Prescription No AB 075109 AMNEAL PHARM
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 074796 MYLAN
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 074145 WATSON LABS

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