Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071617
Company: TEVA PHARMS
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
12/01/1988 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
02/23/2017 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

05/26/2009 SUPPL-27 Labeling

Label is not available on this site.

11/19/2008 SUPPL-26 Labeling

Label is not available on this site.

08/19/2008 SUPPL-25 Labeling

Label is not available on this site.

10/31/2001 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

10/25/2001 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/25/2001 SUPPL-15 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/25/2001 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

01/23/2002 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

02/26/2001 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

10/27/2000 SUPPL-11 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/17/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/23/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/13/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/07/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/02/1997 SUPPL-5 Labeling

Label is not available on this site.

05/31/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/29/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/10/1991 SUPPL-2 Labeling

Label is not available on this site.

10/21/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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