Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071015
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOPERIDOL 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
08/25/1987 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
08/30/2001 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

07/08/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/02/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/02/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/02/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/21/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/21/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/21/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/21/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/21/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/21/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/08/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/12/1989 SUPPL-4 Labeling

Label is not available on this site.

08/29/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/22/1988 SUPPL-2 Labeling

Label is not available on this site.

01/27/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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