Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074145
Company: WATSON LABS
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 No
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET;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
10/17/1995 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
11/30/2016 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

07/16/2003 SUPPL-9 Labeling

Label is not available on this site.

08/05/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/2002 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

09/05/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/2001 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/10/1999 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/18/1998 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 074673 EPIC PHARMA LLC
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 074673 EPIC PHARMA LLC
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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