An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202240
Company: LUPIN LTD

Products on ANDA 202240

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	AB	No	No
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	AB	No	No
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	AB	No	No
CELECOXIB	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202240

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/09/2015	ORIG-2	Approval				Label is not available on this site.
10/29/2014	ORIG-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 Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/05/2022	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/09/2019	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/09/2019	SUPPL-7	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
10/09/2019	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/16/2016	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 202240

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202240Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 202240

CELECOXIB

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CELEBREX	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	Yes	AB	020998	UPJOHN
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	204519	ALEMBIC
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	204197	APOTEX
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	206827	AUROBINDO PHARMA
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	208701	CADILA PHARMS LTD
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	207446	CIPLA
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	210071	CSPC OUYI
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	202240	LUPIN LTD
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	204590	MACLEODS PHARMS LTD
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	204776	MICRO LABS
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	208856	QINGDAO BAHEAL PHARM
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	205129	SCIEGEN PHARMS INC
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	076898	TEVA
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	207872	TIANJIN TIANYAO
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	207677	TORRENT
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	210628	UMEDICA
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	200562	WATSON LABS INC
CELECOXIB	CELECOXIB	50MG	CAPSULE;ORAL	Prescription	No	AB	211412	YILING

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CELEBREX	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	Yes	AB	020998	UPJOHN
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	204519	ALEMBIC
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	204197	APOTEX
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	206827	AUROBINDO PHARMA
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	208701	CADILA PHARMS LTD
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	207446	CIPLA
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	210071	CSPC OUYI
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	202240	LUPIN LTD
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	204590	MACLEODS PHARMS LTD
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	204776	MICRO LABS
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	208856	QINGDAO BAHEAL PHARM
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	205129	SCIEGEN PHARMS INC
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	076898	TEVA
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	207872	TIANJIN TIANYAO
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	207677	TORRENT
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	210628	UMEDICA
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	200562	WATSON LABS INC
CELECOXIB	CELECOXIB	100MG	CAPSULE;ORAL	Prescription	No	AB	211412	YILING

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CELEBREX	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	Yes	AB	020998	UPJOHN
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	204519	ALEMBIC
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	204197	APOTEX
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	206827	AUROBINDO PHARMA
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	208701	CADILA PHARMS LTD
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	207446	CIPLA
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	210071	CSPC OUYI
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	202240	LUPIN LTD
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	204590	MACLEODS PHARMS LTD
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	204776	MICRO LABS
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	213598	NANJING
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	208856	QINGDAO BAHEAL PHARM
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	205129	SCIEGEN PHARMS INC
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	076898	TEVA
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	207872	TIANJIN TIANYAO
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	207677	TORRENT
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	210628	UMEDICA
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	200562	WATSON LABS INC
CELECOXIB	CELECOXIB	200MG	CAPSULE;ORAL	Prescription	No	AB	211412	YILING

CAPSULE;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CELEBREX	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	Yes	AB	020998	UPJOHN
CELECOXIB	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	No	AB	204519	ALEMBIC
CELECOXIB	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	No	AB	206827	AUROBINDO PHARMA
CELECOXIB	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	No	AB	208701	CADILA PHARMS LTD
CELECOXIB	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	No	AB	207446	CIPLA
CELECOXIB	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	No	AB	202240	LUPIN LTD
CELECOXIB	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	No	AB	204590	MACLEODS PHARMS LTD
CELECOXIB	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	No	AB	204776	MICRO LABS
CELECOXIB	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	No	AB	208856	QINGDAO BAHEAL PHARM
CELECOXIB	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	No	AB	205129	SCIEGEN PHARMS INC
CELECOXIB	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	No	AB	076898	TEVA
CELECOXIB	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	No	AB	207872	TIANJIN TIANYAO
CELECOXIB	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	No	AB	207677	TORRENT
CELECOXIB	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	No	AB	210628	UMEDICA
CELECOXIB	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	No	AB	200562	WATSON LABS INC
CELECOXIB	CELECOXIB	400MG	CAPSULE;ORAL	Prescription	No	AB	211412	YILING

Top