Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075109
Company: AMNEAL PHARM
Company: AMNEAL PHARM
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 | 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 |
---|---|---|---|---|---|---|---|
11/25/1998 | 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 |
---|---|---|---|---|---|
02/19/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
11/04/2002 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
06/22/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
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 |