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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071072
Company: PUREPAC PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOPERIDOL HALOPERIDOL 1MG 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
11/03/1986 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
05/09/1991 SUPPL-11 Labeling

Label is not available on this site.

04/19/1989 SUPPL-10 Labeling

Label is not available on this site.

02/20/1998 SUPPL-6 Labeling

Label is not available on this site.

02/20/1998 SUPPL-4 Labeling

Label is not available on this site.

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