Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077944
Company: LUPIN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MELOXICAM MELOXICAM 7.5MG TABLET;ORAL Prescription AB No No
MELOXICAM MELOXICAM 15MG TABLET;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
07/19/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77944ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/04/2016 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

10/04/2016 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

07/01/2015 SUPPL-12 Labeling-Container/Carton Labels

Label is not available on this site.

01/28/2011 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/30/2010 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/27/2008 SUPPL-3 Labeling

Label is not available on this site.

03/29/2007 SUPPL-1 Labeling

Label is not available on this site.

MELOXICAM

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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