Drugs@FDA: FDA-Approved Drugs
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HALOPERIDOL | HALOPERIDOL | 10MG | 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 |
---|---|---|---|---|---|
02/23/2017 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
12/06/2010 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
07/16/2009 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
09/08/2008 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
05/29/2008 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
04/02/2008 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
12/11/2002 | SUPPL-19 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
12/11/2002 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/11/2002 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
09/05/2002 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
05/09/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/14/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/28/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/16/2001 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
10/31/2000 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/04/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/05/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/06/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/21/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
09/21/1998 | 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; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HALOPERIDOL | HALOPERIDOL | 10MG | TABLET;ORAL | Prescription | No | AB | 218789 | AUROBINDO PHARMA LTD |
HALOPERIDOL | HALOPERIDOL | 10MG | TABLET;ORAL | Prescription | No | AB | 071210 | CHARTWELL RX |
HALOPERIDOL | HALOPERIDOL | 10MG | TABLET;ORAL | Prescription | No | AB | 071173 | INNOGENIX |
HALOPERIDOL | HALOPERIDOL | 10MG | TABLET;ORAL | Prescription | No | AB | 216918 | MANKIND PHARMA |
HALOPERIDOL | HALOPERIDOL | 10MG | TABLET;ORAL | Prescription | No | AB | 216004 | MSN |
HALOPERIDOL | HALOPERIDOL | 10MG | TABLET;ORAL | Prescription | No | AB | 070278 | MYLAN |
HALOPERIDOL | HALOPERIDOL | 10MG | TABLET;ORAL | Prescription | No | AB | 071130 | SCIEGEN PHARMS INC |
HALOPERIDOL | HALOPERIDOL | 10MG | TABLET;ORAL | Prescription | No | AB | 211061 | UPSHER SMITH LABS |
HALOPERIDOL | HALOPERIDOL | 10MG | TABLET;ORAL | Prescription | No | AB | 077580 | ZYDUS PHARMS USA |