Drugs@FDA: FDA-Approved Drugs
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HALOPERIDOL | HALOPERIDOL | 20MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/11/1988 | 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 |
|---|---|---|---|---|---|
| 01/22/2025 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/23/2017 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/06/2010 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2009 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/08/2008 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 05/29/2008 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 04/02/2008 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/05/2002 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/19/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/09/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/16/2001 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/31/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/01/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/09/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/26/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
HALOPERIDOL
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HALOPERIDOL | HALOPERIDOL | 20MG | TABLET;ORAL | Prescription | No | AB | 211061 | APPCO |
| HALOPERIDOL | HALOPERIDOL | 20MG | TABLET;ORAL | Prescription | No | AB | 218789 | AUROBINDO PHARMA LTD |
| HALOPERIDOL | HALOPERIDOL | 20MG | TABLET;ORAL | Prescription | No | AB | 071211 | CHARTWELL RX |
| HALOPERIDOL | HALOPERIDOL | 20MG | TABLET;ORAL | Prescription | No | AB | 218162 | CREEKWOOD PHARMS |
| HALOPERIDOL | HALOPERIDOL | 20MG | TABLET;ORAL | Prescription | No | AB | 071173 | INNOGENIX |
| HALOPERIDOL | HALOPERIDOL | 20MG | TABLET;ORAL | Prescription | No | AB | 216918 | MANKIND PHARMA |
| HALOPERIDOL | HALOPERIDOL | 20MG | TABLET;ORAL | Prescription | No | AB | 216004 | MSN |
| HALOPERIDOL | HALOPERIDOL | 20MG | TABLET;ORAL | Prescription | No | AB | 070278 | MYLAN |
| HALOPERIDOL | HALOPERIDOL | 20MG | TABLET;ORAL | Prescription | No | AB | 077580 | ZYDUS PHARMS USA |