Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071173
Company: INNOGENIX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOPERIDOL HALOPERIDOL 10MG TABLET;ORAL Prescription AB No No
HALOPERIDOL HALOPERIDOL 0.5MG TABLET;ORAL Prescription AB No No
HALOPERIDOL HALOPERIDOL 1MG TABLET;ORAL Prescription AB No No
HALOPERIDOL HALOPERIDOL 2MG TABLET;ORAL Prescription AB No No
HALOPERIDOL HALOPERIDOL 5MG 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
01/07/1988 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
04/26/2017 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

12/01/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

04/03/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/12/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/12/1990 SUPPL-4 Labeling

Label is not available on this site.

09/12/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/15/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/15/1988 SUPPL-1 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; 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

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; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALOPERIDOL HALOPERIDOL 2MG TABLET;ORAL Prescription No AB 071173 INNOGENIX

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; 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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