Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074145
Company: WATSON LABS
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 | 217293 | AJANTA PHARMA LTD |
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 | AUROBINDO PHARMA USA |
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 | 216828 | I 3 PHARMS |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 216762 | RUBICON |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 216399 | TWI PHARMS |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 214689 | UNICHEM |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 074145 | WATSON LABS |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 218326 | XIROMED |
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 | 217293 | AJANTA PHARMA LTD |
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 | AUROBINDO PHARMA USA |
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 | 216828 | I 3 PHARMS |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 216762 | RUBICON |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 216399 | TWI PHARMS |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 214689 | UNICHEM |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 074145 | WATSON LABS |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 218326 | XIROMED |