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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211061
Company: UPSHER SMITH LABS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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 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
01/08/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

HALOPERIDOL

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 218789 AUROBINDO PHARMA LTD
HALOPERIDOL HALOPERIDOL 0.5MG TABLET;ORAL Prescription No AB 071209 CHARTWELL RX
HALOPERIDOL HALOPERIDOL 0.5MG TABLET;ORAL Prescription No AB 071173 INNOGENIX
HALOPERIDOL HALOPERIDOL 0.5MG TABLET;ORAL Prescription No AB 216918 MANKIND PHARMA
HALOPERIDOL HALOPERIDOL 0.5MG TABLET;ORAL Prescription No AB 216004 MSN
HALOPERIDOL HALOPERIDOL 0.5MG TABLET;ORAL Prescription No AB 070278 MYLAN
HALOPERIDOL HALOPERIDOL 0.5MG TABLET;ORAL Prescription No AB 071206 SANDOZ
HALOPERIDOL HALOPERIDOL 0.5MG TABLET;ORAL Prescription No AB 211061 UPSHER SMITH LABS
HALOPERIDOL HALOPERIDOL 0.5MG 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 218789 AUROBINDO PHARMA LTD
HALOPERIDOL HALOPERIDOL 1MG TABLET;ORAL Prescription No AB 071209 CHARTWELL RX
HALOPERIDOL HALOPERIDOL 1MG TABLET;ORAL Prescription No AB 071173 INNOGENIX
HALOPERIDOL HALOPERIDOL 1MG TABLET;ORAL Prescription No AB 216918 MANKIND PHARMA
HALOPERIDOL HALOPERIDOL 1MG TABLET;ORAL Prescription No AB 216004 MSN
HALOPERIDOL HALOPERIDOL 1MG TABLET;ORAL Prescription No AB 070278 MYLAN
HALOPERIDOL HALOPERIDOL 1MG TABLET;ORAL Prescription No AB 071207 SANDOZ
HALOPERIDOL HALOPERIDOL 1MG TABLET;ORAL Prescription No AB 211061 UPSHER SMITH LABS
HALOPERIDOL HALOPERIDOL 1MG TABLET;ORAL Prescription No AB 077580 ZYDUS PHARMS USA

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 218789 AUROBINDO PHARMA LTD
HALOPERIDOL HALOPERIDOL 2MG TABLET;ORAL Prescription No AB 071173 INNOGENIX
HALOPERIDOL HALOPERIDOL 2MG TABLET;ORAL Prescription No AB 216918 MANKIND PHARMA
HALOPERIDOL HALOPERIDOL 2MG TABLET;ORAL Prescription No AB 216004 MSN
HALOPERIDOL HALOPERIDOL 2MG TABLET;ORAL Prescription No AB 070278 MYLAN
HALOPERIDOL HALOPERIDOL 2MG TABLET;ORAL Prescription No AB 071130 SCIEGEN PHARMS INC
HALOPERIDOL HALOPERIDOL 2MG TABLET;ORAL Prescription No AB 211061 UPSHER SMITH LABS
HALOPERIDOL HALOPERIDOL 2MG TABLET;ORAL Prescription No AB 077580 ZYDUS PHARMS USA

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 218789 AUROBINDO PHARMA LTD
HALOPERIDOL HALOPERIDOL 5MG TABLET;ORAL Prescription No AB 071209 CHARTWELL RX
HALOPERIDOL HALOPERIDOL 5MG TABLET;ORAL Prescription No AB 071173 INNOGENIX
HALOPERIDOL HALOPERIDOL 5MG TABLET;ORAL Prescription No AB 216918 MANKIND PHARMA
HALOPERIDOL HALOPERIDOL 5MG TABLET;ORAL Prescription No AB 216004 MSN
HALOPERIDOL HALOPERIDOL 5MG TABLET;ORAL Prescription No AB 070278 MYLAN
HALOPERIDOL HALOPERIDOL 5MG TABLET;ORAL Prescription No AB 071131 SCIEGEN PHARMS INC
HALOPERIDOL HALOPERIDOL 5MG TABLET;ORAL Prescription No AB 211061 UPSHER SMITH LABS
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 218789 AUROBINDO PHARMA LTD
HALOPERIDOL HALOPERIDOL 10MG TABLET;ORAL Prescription No AB 071210 CHARTWELL RX
HALOPERIDOL HALOPERIDOL 10MG TABLET;ORAL Prescription No AB 071173 INNOGENIX
HALOPERIDOL HALOPERIDOL 10MG TABLET;ORAL Prescription No AB 216918 MANKIND PHARMA
HALOPERIDOL HALOPERIDOL 10MG TABLET;ORAL Prescription No AB 216004 MSN
HALOPERIDOL HALOPERIDOL 10MG TABLET;ORAL Prescription No AB 070278 MYLAN
HALOPERIDOL HALOPERIDOL 10MG TABLET;ORAL Prescription No AB 071132 SCIEGEN PHARMS INC
HALOPERIDOL HALOPERIDOL 10MG TABLET;ORAL Prescription No AB 211061 UPSHER SMITH LABS
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 218789 AUROBINDO PHARMA LTD
HALOPERIDOL HALOPERIDOL 20MG TABLET;ORAL Prescription No AB 071211 CHARTWELL RX
HALOPERIDOL HALOPERIDOL 20MG TABLET;ORAL Prescription No AB 071173 INNOGENIX
HALOPERIDOL HALOPERIDOL 20MG TABLET;ORAL Prescription No AB 216918 MANKIND PHARMA
HALOPERIDOL HALOPERIDOL 20MG TABLET;ORAL Prescription No AB 216004 MSN
HALOPERIDOL HALOPERIDOL 20MG TABLET;ORAL Prescription No AB 070278 MYLAN
HALOPERIDOL HALOPERIDOL 20MG TABLET;ORAL Prescription No AB 211061 UPSHER SMITH LABS
HALOPERIDOL HALOPERIDOL 20MG TABLET;ORAL Prescription No AB 077580 ZYDUS PHARMS USA
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