Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206827
Company: AUROBINDO PHARMA LTD
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/01/2016 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206827Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206827Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/09/2019 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

07/25/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

09/14/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/01/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206827Orig1s000lbl.pdf

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 GD SEARLE
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 204519 ALEMBIC PHARMS LTD
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 208833 AMNEAL PHARMS
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 204197 APOTEX INC
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 206827 AUROBINDO PHARMA 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 207061 JUBILANT GENERICS
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 078857 MYLAN
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 208856 QINGDAO BAHEAL PHARM
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 076898 TEVA
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 207677 TORRENT
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription No AB 200562 WATSON LABS INC

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 GD SEARLE
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 204519 ALEMBIC PHARMS LTD
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 208833 AMNEAL PHARMS
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 204197 APOTEX INC
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 206827 AUROBINDO PHARMA 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 207061 JUBILANT GENERICS
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 078857 MYLAN
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 208856 QINGDAO BAHEAL PHARM
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 076898 TEVA
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 207677 TORRENT
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription No AB 200562 WATSON LABS INC

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 GD SEARLE
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 204519 ALEMBIC PHARMS LTD
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 208833 AMNEAL PHARMS
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 204197 APOTEX INC
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 206827 AUROBINDO PHARMA 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 207061 JUBILANT GENERICS
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 078857 MYLAN
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 208856 QINGDAO BAHEAL PHARM
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 076898 TEVA
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 207677 TORRENT
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription No AB 200562 WATSON LABS INC

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 GD SEARLE
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 204519 ALEMBIC PHARMS LTD
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 208833 AMNEAL PHARMS
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 206827 AUROBINDO PHARMA LTD
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 207446 CIPLA
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 207061 JUBILANT GENERICS
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 078857 MYLAN
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 208856 QINGDAO BAHEAL PHARM
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 076898 TEVA
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 207677 TORRENT
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription No AB 200562 WATSON LABS INC

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