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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200854
Company: ACTAVIS GROUP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOPERIDOL HALOPERIDOL 0.5MG TABLET;ORAL Discontinued None No No
HALOPERIDOL HALOPERIDOL 1MG TABLET;ORAL Discontinued None No No
HALOPERIDOL HALOPERIDOL 2MG TABLET;ORAL Discontinued None No No
HALOPERIDOL HALOPERIDOL 5MG TABLET;ORAL Discontinued None No No
HALOPERIDOL HALOPERIDOL 10MG TABLET;ORAL Discontinued None No No
HALOPERIDOL HALOPERIDOL 20MG TABLET;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
07/01/2022 ORIG-1 Approval Not Applicable

Label is not available on this site.

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