Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071237
Company: VINTAGE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOPERIDOL HALOPERIDOL 10MG 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
07/20/1987 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
03/18/2015 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/27/1993 SUPPL-14 Labeling

Label is not available on this site.

03/09/1989 SUPPL-13 Labeling

Label is not available on this site.

11/20/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/15/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/24/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/24/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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