Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075689
Company: FRESENIUS KABI USA
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
03/09/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75689ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/08/2018 SUPPL-20 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

09/15/2015 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

09/15/2015 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

09/27/2011 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

12/06/2010 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

03/14/2009 SUPPL-10 Labeling

Label is not available on this site.

10/30/2008 SUPPL-9 Labeling

Label is not available on this site.

12/05/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

10/07/2002 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/24/2001 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
HALDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 015923 JANSSEN PHARMS
HALOPERIDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204849 AKORN
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 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
HALOPERIDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076035 TEVA PHARMS USA
HALOPERIDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075858 WEST-WARD PHARMS INT

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