Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072045
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOPERIDOL INTENSOL HALOPERIDOL LACTATE EQ 2MG BASE/ML CONCENTRATE;ORAL Discontinued None 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
04/12/1988 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
02/26/1990 SUPPL-5 Labeling

Label is not available on this site.

09/13/1988 SUPPL-2 Labeling

Label is not available on this site.

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