Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207677
Company: TORRENT
Company: TORRENT
| 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 |
|---|---|---|---|---|---|---|---|
| 12/23/2015 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/01/2022 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/20/2019 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 08/20/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/15/2016 | SUPPL-1 | 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 | 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 |