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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203828
Company: INDCHEMIE HEALTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription AB No No
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription AB No No
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription AB No No
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE 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
07/29/2015 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
08/25/2023 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

11/19/2021 SUPPL-3 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

NEBIVOLOL HYDROCHLORIDE

TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription Yes AB 021742 ALLERGAN
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 203659 ANI PHARMS
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 211053 AUROBINDO PHARMA LTD
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 216568 BEXIMCO PHARMS USA
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 208717 CADILA PHARMS LTD
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 203825 HETERO LABS LTD III
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 203828 INDCHEMIE HEALTH
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 216172 MANKIND PHARMA
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 212682 PRINSTON INC
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 212917 REYOUNG
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 203966 TORRENT

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription Yes AB 021742 ALLERGAN
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 203659 ANI PHARMS
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 211053 AUROBINDO PHARMA LTD
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 216568 BEXIMCO PHARMS USA
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 208717 CADILA PHARMS LTD
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 203825 HETERO LABS LTD III
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 203828 INDCHEMIE HEALTH
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 216172 MANKIND PHARMA
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 212682 PRINSTON INC
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 212917 REYOUNG
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 203966 TORRENT

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription Yes AB 021742 ALLERGAN
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 203659 ANI PHARMS
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 211053 AUROBINDO PHARMA LTD
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 216568 BEXIMCO PHARMS USA
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 208717 CADILA PHARMS LTD
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 203825 HETERO LABS LTD III
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 203828 INDCHEMIE HEALTH
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 216172 MANKIND PHARMA
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 212682 PRINSTON INC
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 212917 REYOUNG
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 203966 TORRENT

TABLET;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription Yes AB 021742 ALLERGAN
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 203659 ANI PHARMS
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 211053 AUROBINDO PHARMA LTD
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 216568 BEXIMCO PHARMS USA
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 208717 CADILA PHARMS LTD
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 203825 HETERO LABS LTD III
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 203828 INDCHEMIE HEALTH
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 216172 MANKIND PHARMA
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 212682 PRINSTON INC
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 212917 REYOUNG
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 203966 TORRENT
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