Drugs@FDA: FDA-Approved Drugs
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HALOPERIDOL | HALOPERIDOL LACTATE | EQ 2MG BASE/ML | CONCENTRATE;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 |
|---|---|---|---|---|---|---|---|
| 12/01/1988 | 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 |
|---|---|---|---|---|---|
| 02/23/2017 | SUPPL-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/03/2010 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/26/2009 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 11/19/2008 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 08/19/2008 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/25/2001 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/25/2001 | SUPPL-15 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 10/25/2001 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/23/2002 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/26/2001 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/27/2000 | SUPPL-11 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 06/17/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/21/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |