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Abbreviated New Drug Application (ANDA): 076898
Company: TEVA
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
05/30/2014 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/076898Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/16/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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 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 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 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 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 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 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 208701 CADILA PHARMS 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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