Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020938
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOBIC MELOXICAM 7.5MG TABLET;ORAL Prescription AB Yes No
MOBIC MELOXICAM 15MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/13/2000 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20938lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20938ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-938_Mobic.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2021 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020938Orig1s028ltr.pdf
06/30/2016 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s026ltr.pdf
05/09/2016 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s024,s025,021530Origs014,s015ltr.pdf
05/09/2016 SUPPL-24 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s024,s025,021530Origs014,s015ltr.pdf
03/05/2012 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020938s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020938s022,021530s011ltr.pdf
08/03/2011 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020938s021,021530s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020938s021,021530s009ltr.pdf
07/29/2010 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020938s020,021530s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020938s020,021530s008ltr.pdf
04/26/2010 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020938s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020938s019,021530s007ltr.pdf
06/27/2008 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020938s018,021530s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020938s018, 021530s006ltr.pdf
01/25/2007 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020938s017,021530s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020938s017, 021530s005ltr.pdf
08/11/2005 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020938s013,015,021530s001,003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020938s013,015,021530s001,003ltr.pdf
08/11/2005 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020938s013,015,021530s001,003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020938s013,015,021530s001,003ltr.pdf
12/13/2002 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/21/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/2003 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020938s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20938slr007ltr.pdf
06/10/2002 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/10/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/16/2004 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20938s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20938s004ltr.pdf
12/15/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/14/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/23/2000 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/28/2021 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf
06/30/2016 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s026lbl.pdf
05/09/2016 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf
05/09/2016 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf
05/09/2016 SUPPL-24 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf
05/09/2016 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf
03/05/2012 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020938s022lbl.pdf
08/03/2011 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020938s021,021530s009lbl.pdf
07/29/2010 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020938s020,021530s008lbl.pdf
04/26/2010 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020938s019lbl.pdf
06/27/2008 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020938s018,021530s006lbl.pdf
01/25/2007 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020938s017,021530s005lbl.pdf
08/11/2005 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020938s013,015,021530s001,003lbl.pdf
08/11/2005 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020938s013,015,021530s001,003lbl.pdf
07/16/2004 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20938s004lbl.pdf
04/28/2003 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020938s007lbl.pdf
04/13/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20938lbl.pdf

MOBIC

TABLET;ORAL; 7.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MELOXICAM MELOXICAM 7.5MG TABLET;ORAL Prescription No AB 077882 APOTEX INC
MELOXICAM MELOXICAM 7.5MG TABLET;ORAL Prescription No AB 078008 AUROBINDO PHARMA
MELOXICAM MELOXICAM 7.5MG TABLET;ORAL Prescription No AB 077929 CIPLA
MELOXICAM MELOXICAM 7.5MG TABLET;ORAL Prescription No AB 077931 DR REDDYS LABS INC
MELOXICAM MELOXICAM 7.5MG TABLET;ORAL Prescription No AB 077932 GLENMARK GENERICS
MELOXICAM MELOXICAM 7.5MG TABLET;ORAL Prescription No AB 077944 LUPIN PHARMS
MELOXICAM MELOXICAM 7.5MG TABLET;ORAL Prescription No AB 077938 PURACAP PHARM
MELOXICAM MELOXICAM 7.5MG TABLET;ORAL Prescription No AB 077928 STRIDES PHARMA
MELOXICAM MELOXICAM 7.5MG TABLET;ORAL Prescription No AB 078102 TARO
MELOXICAM MELOXICAM 7.5MG TABLET;ORAL Prescription No AB 077927 UNICHEM
MELOXICAM MELOXICAM 7.5MG TABLET;ORAL Prescription No AB 077918 YUNG SHIN PHARM
MELOXICAM MELOXICAM 7.5MG TABLET;ORAL Prescription No AB 077921 ZYDUS PHARMS USA
MOBIC MELOXICAM 7.5MG TABLET;ORAL Prescription Yes AB 020938 BOEHRINGER INGELHEIM

TABLET;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MELOXICAM MELOXICAM 15MG TABLET;ORAL Prescription No AB 077882 APOTEX INC
MELOXICAM MELOXICAM 15MG TABLET;ORAL Prescription No AB 078008 AUROBINDO PHARMA
MELOXICAM MELOXICAM 15MG TABLET;ORAL Prescription No AB 077929 CIPLA
MELOXICAM MELOXICAM 15MG TABLET;ORAL Prescription No AB 077931 DR REDDYS LABS INC
MELOXICAM MELOXICAM 15MG TABLET;ORAL Prescription No AB 077932 GLENMARK GENERICS
MELOXICAM MELOXICAM 15MG TABLET;ORAL Prescription No AB 077944 LUPIN PHARMS
MELOXICAM MELOXICAM 15MG TABLET;ORAL Prescription No AB 077938 PURACAP PHARM
MELOXICAM MELOXICAM 15MG TABLET;ORAL Prescription No AB 077928 STRIDES PHARMA
MELOXICAM MELOXICAM 15MG TABLET;ORAL Prescription No AB 078102 TARO
MELOXICAM MELOXICAM 15MG TABLET;ORAL Prescription No AB 077927 UNICHEM
MELOXICAM MELOXICAM 15MG TABLET;ORAL Prescription No AB 077918 YUNG SHIN PHARM
MELOXICAM MELOXICAM 15MG TABLET;ORAL Prescription No AB 077921 ZYDUS PHARMS USA
MOBIC MELOXICAM 15MG TABLET;ORAL Prescription Yes AB 020938 BOEHRINGER INGELHEIM

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