Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070278
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HALOPERIDOL | HALOPERIDOL | 2MG | TABLET;ORAL | Prescription | AB | No | Yes |
| HALOPERIDOL | HALOPERIDOL | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| HALOPERIDOL | HALOPERIDOL | 20MG | TABLET;ORAL | Prescription | AB | No | No |
| HALOPERIDOL | HALOPERIDOL | 1MG | TABLET;ORAL | Prescription | AB | No | No |
| HALOPERIDOL | HALOPERIDOL | 5MG | TABLET;ORAL | Prescription | AB | No | No |
| HALOPERIDOL | HALOPERIDOL | 0.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/10/1986 | 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 |
|---|---|---|---|---|---|
| 06/29/2022 | SUPPL-38 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/23/2017 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/10/2012 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/27/2011 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/03/2010 | SUPPL-27 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/25/2008 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 07/16/2009 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 05/29/2008 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 04/05/2004 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/06/2001 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 09/20/2000 | SUPPL-15 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/11/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/11/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/28/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
HALOPERIDOL
TABLET;ORAL; 2MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HALOPERIDOL | HALOPERIDOL | 2MG | TABLET;ORAL | Prescription | No | AB | 218789 | AUROBINDO PHARMA LTD |
| HALOPERIDOL | HALOPERIDOL | 2MG | TABLET;ORAL | Prescription | No | AB | 071173 | INNOGENIX |
| HALOPERIDOL | HALOPERIDOL | 2MG | TABLET;ORAL | Prescription | No | AB | 216918 | MANKIND PHARMA |
| HALOPERIDOL | HALOPERIDOL | 2MG | TABLET;ORAL | Prescription | No | AB | 216004 | MSN |
| HALOPERIDOL | HALOPERIDOL | 2MG | TABLET;ORAL | Prescription | No | AB | 070278 | MYLAN |
| HALOPERIDOL | HALOPERIDOL | 2MG | TABLET;ORAL | Prescription | No | AB | 071130 | SCIEGEN PHARMS INC |
| HALOPERIDOL | HALOPERIDOL | 2MG | TABLET;ORAL | Prescription | No | AB | 211061 | UPSHER SMITH LABS |
| HALOPERIDOL | HALOPERIDOL | 2MG | TABLET;ORAL | Prescription | No | AB | 077580 | ZYDUS PHARMS USA |
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 | 071132 | 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 |
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 | 218789 | AUROBINDO PHARMA LTD |
| HALOPERIDOL | HALOPERIDOL | 20MG | TABLET;ORAL | Prescription | No | AB | 071211 | CHARTWELL RX |
| 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 | 211061 | UPSHER SMITH LABS |
| HALOPERIDOL | HALOPERIDOL | 20MG | TABLET;ORAL | Prescription | No | AB | 077580 | ZYDUS PHARMS USA |
TABLET;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HALOPERIDOL | HALOPERIDOL | 1MG | TABLET;ORAL | Prescription | No | AB | 218789 | AUROBINDO PHARMA LTD |
| HALOPERIDOL | HALOPERIDOL | 1MG | TABLET;ORAL | Prescription | No | AB | 071209 | CHARTWELL RX |
| HALOPERIDOL | HALOPERIDOL | 1MG | TABLET;ORAL | Prescription | No | AB | 071173 | INNOGENIX |
| HALOPERIDOL | HALOPERIDOL | 1MG | TABLET;ORAL | Prescription | No | AB | 216918 | MANKIND PHARMA |
| HALOPERIDOL | HALOPERIDOL | 1MG | TABLET;ORAL | Prescription | No | AB | 216004 | MSN |
| HALOPERIDOL | HALOPERIDOL | 1MG | TABLET;ORAL | Prescription | No | AB | 070278 | MYLAN |
| HALOPERIDOL | HALOPERIDOL | 1MG | TABLET;ORAL | Prescription | No | AB | 071207 | SANDOZ |
| HALOPERIDOL | HALOPERIDOL | 1MG | TABLET;ORAL | Prescription | No | AB | 211061 | UPSHER SMITH LABS |
| HALOPERIDOL | HALOPERIDOL | 1MG | TABLET;ORAL | Prescription | No | AB | 077580 | ZYDUS PHARMS USA |
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HALOPERIDOL | HALOPERIDOL | 5MG | TABLET;ORAL | Prescription | No | AB | 218789 | AUROBINDO PHARMA LTD |
| HALOPERIDOL | HALOPERIDOL | 5MG | TABLET;ORAL | Prescription | No | AB | 071209 | CHARTWELL RX |
| HALOPERIDOL | HALOPERIDOL | 5MG | TABLET;ORAL | Prescription | No | AB | 071173 | INNOGENIX |
| HALOPERIDOL | HALOPERIDOL | 5MG | TABLET;ORAL | Prescription | No | AB | 216918 | MANKIND PHARMA |
| HALOPERIDOL | HALOPERIDOL | 5MG | TABLET;ORAL | Prescription | No | AB | 216004 | MSN |
| HALOPERIDOL | HALOPERIDOL | 5MG | TABLET;ORAL | Prescription | No | AB | 070278 | MYLAN |
| HALOPERIDOL | HALOPERIDOL | 5MG | TABLET;ORAL | Prescription | No | AB | 071131 | SCIEGEN PHARMS INC |
| HALOPERIDOL | HALOPERIDOL | 5MG | TABLET;ORAL | Prescription | No | AB | 211061 | UPSHER SMITH LABS |
| HALOPERIDOL | HALOPERIDOL | 5MG | TABLET;ORAL | Prescription | No | AB | 077580 | ZYDUS PHARMS USA |
TABLET;ORAL; 0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HALOPERIDOL | HALOPERIDOL | 0.5MG | TABLET;ORAL | Prescription | No | AB | 218789 | AUROBINDO PHARMA LTD |
| HALOPERIDOL | HALOPERIDOL | 0.5MG | TABLET;ORAL | Prescription | No | AB | 071209 | CHARTWELL RX |
| HALOPERIDOL | HALOPERIDOL | 0.5MG | TABLET;ORAL | Prescription | No | AB | 071173 | INNOGENIX |
| HALOPERIDOL | HALOPERIDOL | 0.5MG | TABLET;ORAL | Prescription | No | AB | 216918 | MANKIND PHARMA |
| HALOPERIDOL | HALOPERIDOL | 0.5MG | TABLET;ORAL | Prescription | No | AB | 216004 | MSN |
| HALOPERIDOL | HALOPERIDOL | 0.5MG | TABLET;ORAL | Prescription | No | AB | 070278 | MYLAN |
| HALOPERIDOL | HALOPERIDOL | 0.5MG | TABLET;ORAL | Prescription | No | AB | 071206 | SANDOZ |
| HALOPERIDOL | HALOPERIDOL | 0.5MG | TABLET;ORAL | Prescription | No | AB | 211061 | UPSHER SMITH LABS |
| HALOPERIDOL | HALOPERIDOL | 0.5MG | TABLET;ORAL | Prescription | No | AB | 077580 | ZYDUS PHARMS USA |