Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071130
Company: SCIEGEN PHARMS INC
Company: SCIEGEN PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HALOPERIDOL | HALOPERIDOL | 2MG | TABLET;ORAL | Prescription | AB | No | No |
HALOPERIDOL | HALOPERIDOL | 5MG | TABLET;ORAL | Prescription | AB | No | No |
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 |
---|---|---|---|---|---|---|---|
02/17/1987 | 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 |
---|---|---|---|---|---|
02/17/2021 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
05/09/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
12/12/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
06/14/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
10/25/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
02/23/1988 | SUPPL-3 | Labeling |
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; 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; 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 |