CELECOXIB از شرکت LUPIN LTD
Abbreviated New Drug Application (ANDA): 202240
Company: LUPIN 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 |
|---|---|---|---|---|---|---|---|
| 06/09/2015 | ORIG-2 | Approval |
|
Label is not available on this site. |
|||
| 10/29/2014 | ORIG-1 | Approval |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202240Orig1s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/09/2019 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/09/2019 | SUPPL-7 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/09/2019 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
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. |
| 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 |
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 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 | 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 | 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 LABS PVT LTD |
| CELECOXIB | CELECOXIB | 50MG | CAPSULE;ORAL | Prescription | No | AB | 213301 | UNICHEM |
| 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 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 | 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 | 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 LABS PVT LTD |
| CELECOXIB | CELECOXIB | 100MG | CAPSULE;ORAL | Prescription | No | AB | 213301 | UNICHEM |
| 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 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 | 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 | 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 LABS PVT LTD |
| CELECOXIB | CELECOXIB | 200MG | CAPSULE;ORAL | Prescription | No | AB | 213301 | UNICHEM |
| 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 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 | 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 | 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 LABS PVT LTD |
| CELECOXIB | CELECOXIB | 400MG | CAPSULE;ORAL | Prescription | No | AB | 213301 | UNICHEM |
| CELECOXIB | CELECOXIB | 400MG | CAPSULE;ORAL | Prescription | No | AB | 200562 | WATSON LABS INC |
| CELECOXIB | CELECOXIB | 400MG | CAPSULE;ORAL | Prescription | No | AB | 211412 | YILING |
حتما بخوانید : BUPIVACAINE HYDROCHLORIDE از شرکت HOSPIRA
منبع : www.accessdata.fda.gov
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