Drugs@FDA: FDA-Approved Drugs
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. |
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02/23/2017 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
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01/10/2012 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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09/27/2011 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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12/03/2010 | SUPPL-27 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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11/25/2008 | SUPPL-25 | Labeling |
Label is not available on this site. |
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07/16/2009 | SUPPL-24 | Labeling |
Label is not available on this site. |
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05/29/2008 | SUPPL-22 | Labeling |
Label is not available on this site. |
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04/05/2004 | SUPPL-17 | Labeling |
Label is not available on this site. |
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11/06/2001 | SUPPL-16 | Labeling |
Label is not available on this site. |
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09/20/2000 | SUPPL-15 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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02/25/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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02/05/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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10/14/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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09/30/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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08/30/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
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07/11/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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05/08/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
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07/11/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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03/07/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
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03/28/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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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 | 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 |
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 | 071130 | 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 |