Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073037
Company: PHARM ASSOC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOPERIDOL HALOPERIDOL LACTATE EQ 2MG BASE/ML CONCENTRATE;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/26/1993 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
02/23/2017 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

08/18/2010 SUPPL-13 Labeling-Container/Carton Labels

Label is not available on this site.

02/26/2010 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

03/12/2009 SUPPL-11 Labeling

Label is not available on this site.

11/25/2008 SUPPL-10 Labeling

Label is not available on this site.

03/27/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/31/1995 SUPPL-3 Labeling

Label is not available on this site.

01/31/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

HALOPERIDOL

CONCENTRATE;ORAL; EQ 2MG BASE/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALOPERIDOL HALOPERIDOL LACTATE EQ 2MG BASE/ML CONCENTRATE;ORAL Prescription No AA 073364 LANNETT CO INC
HALOPERIDOL HALOPERIDOL LACTATE EQ 2MG BASE/ML CONCENTRATE;ORAL Prescription No AA 073037 PHARM ASSOC

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