Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077580
Company: ZYDUS PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOPERIDOL HALOPERIDOL 5MG TABLET; ORAL Prescription None No No
HALOPERIDOL HALOPERIDOL 5MG TABLET;ORAL Prescription AB No No
HALOPERIDOL HALOPERIDOL 10MG TABLET;ORAL Prescription AB No No
HALOPERIDOL HALOPERIDOL 20MG 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
11/29/2007 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-12 Labeling-Package Insert

Label is not available on this site.

01/07/2015 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/27/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

12/06/2010 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/25/2008 SUPPL-2 Labeling

Label is not available on this site.

05/29/2008 SUPPL-1 Labeling

Label is not available on this site.

HALOPERIDOL

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; 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

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