Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HALOPERIDOL | HALOPERIDOL LACTATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
06/18/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75858ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/23/2023 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
10/09/2019 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
06/08/2018 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
06/08/2018 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
11/21/2016 | SUPPL-19 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
11/10/2011 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
11/02/2011 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
12/09/2009 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
11/19/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
05/29/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
02/01/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
10/18/2002 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
09/04/2002 | SUPPL-1 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
HALOPERIDOL
INJECTABLE;INJECTION; EQ 5MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HALOPERIDOL | HALOPERIDOL LACTATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075689 | FRESENIUS KABI USA |
HALOPERIDOL | HALOPERIDOL LACTATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210356 | FRESENIUS KABI USA |
HALOPERIDOL | HALOPERIDOL LACTATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076774 | GLAND PHARMA LTD |
HALOPERIDOL | HALOPERIDOL LACTATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075858 | HIKMA |
HALOPERIDOL | HALOPERIDOL LACTATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078347 | MYLAN LABS LTD |
HALOPERIDOL | HALOPERIDOL LACTATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091637 | SAGENT PHARMS |
HALOPERIDOL | HALOPERIDOL LACTATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 200742 | SAGENT PHARMS |