CELECOXIB از شرکت LUPIN LTD

CELECOXIB از شرکت LUPIN LTD

Abbreviated New Drug Application (ANDA): 202240

Company: LUPIN LTD

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescription

AB

NoNo
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescription

AB

NoNo
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescription

AB

NoNo
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescription

AB

NoNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
06/09/2015ORIG-2 Approval

Label is not available on this site.

10/29/2014ORIG-1 Approval

Label (PDF)

Letter (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202240Orig1s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202240Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202240Orig1s000ltr.pdf

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
10/09/2019SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/09/2019SUPPL-7 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/09/2019SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/16/2016SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
10/29/2014ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202240Orig1s000lbl.pdf

CELECOXIB

CAPSULE;ORAL; 50MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CELEBREXCELECOXIB50MGCAPSULE;ORALPrescriptionYesAB020998UPJOHN
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB204519ALEMBIC PHARMS LTD
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB208833AMNEAL PHARMS
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB204197APOTEX INC
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB206827AUROBINDO PHARMA LTD
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB208701CADILA PHARMS LTD
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB207446CIPLA
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB210071CSPC OUYI
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB202240LUPIN LTD
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB204590MACLEODS PHARMS LTD
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB204776MICRO LABS
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB078857MYLAN
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB208856QINGDAO BAHEAL PHARM
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB205129SCIEGEN PHARMS INC
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB076898TEVA
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB207872TIANJIN TIANYAO
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB207677TORRENT
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB210628UMEDICA LABS PVT LTD
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB213301UNICHEM
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB200562WATSON LABS INC
CELECOXIBCELECOXIB50MGCAPSULE;ORALPrescriptionNoAB211412YILING

CAPSULE;ORAL; 100MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CELEBREXCELECOXIB100MGCAPSULE;ORALPrescriptionYesAB020998UPJOHN
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB204519ALEMBIC PHARMS LTD
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB208833AMNEAL PHARMS
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB204197APOTEX INC
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB206827AUROBINDO PHARMA LTD
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB208701CADILA PHARMS LTD
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB207446CIPLA
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB210071CSPC OUYI
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB202240LUPIN LTD
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB204590MACLEODS PHARMS LTD
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB204776MICRO LABS
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB078857MYLAN
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB208856QINGDAO BAHEAL PHARM
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB205129SCIEGEN PHARMS INC
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB076898TEVA
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB207872TIANJIN TIANYAO
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB207677TORRENT
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB210628UMEDICA LABS PVT LTD
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB213301UNICHEM
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB200562WATSON LABS INC
CELECOXIBCELECOXIB100MGCAPSULE;ORALPrescriptionNoAB211412YILING

CAPSULE;ORAL; 200MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CELEBREXCELECOXIB200MGCAPSULE;ORALPrescriptionYesAB020998UPJOHN
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB204519ALEMBIC PHARMS LTD
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB208833AMNEAL PHARMS
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB204197APOTEX INC
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB206827AUROBINDO PHARMA LTD
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB208701CADILA PHARMS LTD
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB207446CIPLA
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB210071CSPC OUYI
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB202240LUPIN LTD
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB204590MACLEODS PHARMS LTD
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB204776MICRO LABS
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB078857MYLAN
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB213598NANJING
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB208856QINGDAO BAHEAL PHARM
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB205129SCIEGEN PHARMS INC
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB076898TEVA
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB207872TIANJIN TIANYAO
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB207677TORRENT
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB210628UMEDICA LABS PVT LTD
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB213301UNICHEM
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB200562WATSON LABS INC
CELECOXIBCELECOXIB200MGCAPSULE;ORALPrescriptionNoAB211412YILING

CAPSULE;ORAL; 400MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CELEBREXCELECOXIB400MGCAPSULE;ORALPrescriptionYesAB020998UPJOHN
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB204519ALEMBIC PHARMS LTD
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB208833AMNEAL PHARMS
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB206827AUROBINDO PHARMA LTD
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB208701CADILA PHARMS LTD
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB207446CIPLA
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB202240LUPIN LTD
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB204590MACLEODS PHARMS LTD
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB204776MICRO LABS
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB078857MYLAN
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB208856QINGDAO BAHEAL PHARM
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB205129SCIEGEN PHARMS INC
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB076898TEVA
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB207872TIANJIN TIANYAO
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB207677TORRENT
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB210628UMEDICA LABS PVT LTD
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB213301UNICHEM
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB200562WATSON LABS INC
CELECOXIBCELECOXIB400MGCAPSULE;ORALPrescriptionNoAB211412YILING
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