Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070278
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOPERIDOL HALOPERIDOL 2MG TABLET;ORAL Prescription None No Yes
HALOPERIDOL HALOPERIDOL 10MG TABLET;ORAL Prescription AB No No
HALOPERIDOL HALOPERIDOL 20MG TABLET;ORAL Prescription AB No No
HALOPERIDOL HALOPERIDOL 1MG TABLET;ORAL Prescription AB No No
HALOPERIDOL HALOPERIDOL 5MG TABLET;ORAL Prescription AB No No
HALOPERIDOL HALOPERIDOL 0.5MG TABLET;ORAL Prescription AB 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
06/10/1986 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
02/23/2017 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

01/10/2012 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

09/27/2011 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-27 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/25/2008 SUPPL-25 Labeling

Label is not available on this site.

07/16/2009 SUPPL-24 Labeling

Label is not available on this site.

05/29/2008 SUPPL-22 Labeling

Label is not available on this site.

04/05/2004 SUPPL-17 Labeling

Label is not available on this site.

11/06/2001 SUPPL-16 Labeling

Label is not available on this site.

09/20/2000 SUPPL-15 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

02/25/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/14/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/30/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/30/1989 SUPPL-8 Labeling

Label is not available on this site.

07/11/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/08/1989 SUPPL-6 Labeling

Label is not available on this site.

07/11/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/07/1988 SUPPL-4 Labeling

Label is not available on this site.

03/28/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/28/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

HALOPERIDOL

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALOPERIDOL HALOPERIDOL 10MG TABLET;ORAL Prescription No AB 071173 INNOGENIX
HALOPERIDOL HALOPERIDOL 10MG TABLET;ORAL Prescription No AB 070278 MYLAN
HALOPERIDOL HALOPERIDOL 10MG TABLET;ORAL Prescription No AB 071210 SANDOZ
HALOPERIDOL HALOPERIDOL 10MG TABLET;ORAL Prescription No AB 077580 ZYDUS PHARMS USA

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALOPERIDOL HALOPERIDOL 20MG TABLET;ORAL Prescription No AB 071173 INNOGENIX
HALOPERIDOL HALOPERIDOL 20MG TABLET;ORAL Prescription No AB 070278 MYLAN
HALOPERIDOL HALOPERIDOL 20MG TABLET;ORAL Prescription No AB 071211 SANDOZ
HALOPERIDOL HALOPERIDOL 20MG TABLET;ORAL Prescription No AB 077580 ZYDUS PHARMS USA

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALOPERIDOL HALOPERIDOL 1MG TABLET;ORAL Prescription No AB 071173 INNOGENIX
HALOPERIDOL HALOPERIDOL 1MG TABLET;ORAL Prescription No AB 070278 MYLAN
HALOPERIDOL HALOPERIDOL 1MG TABLET;ORAL Prescription No AB 071207 SANDOZ

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALOPERIDOL HALOPERIDOL 5MG TABLET;ORAL Prescription No AB 071173 INNOGENIX
HALOPERIDOL HALOPERIDOL 5MG TABLET;ORAL Prescription No AB 070278 MYLAN
HALOPERIDOL HALOPERIDOL 5MG TABLET;ORAL Prescription No AB 071209 SANDOZ
HALOPERIDOL HALOPERIDOL 5MG TABLET;ORAL Prescription No AB 077580 ZYDUS PHARMS USA

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALOPERIDOL HALOPERIDOL 0.5MG TABLET;ORAL Prescription No AB 071173 INNOGENIX
HALOPERIDOL HALOPERIDOL 0.5MG TABLET;ORAL Prescription No AB 070278 MYLAN
HALOPERIDOL HALOPERIDOL 0.5MG TABLET;ORAL Prescription No AB 071206 SANDOZ

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