Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074762
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 | Discontinued | None | No | No |
| GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 06/25/1997 | 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 |
|---|---|---|---|---|---|
| 03/27/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/21/2000 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/02/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |