Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077932
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
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/2006/77932ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/07/2022 | SUPPL-10 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
09/25/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
09/25/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
09/25/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
06/10/2013 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
06/10/2013 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
06/15/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
08/14/2007 | 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 | 077920 | AIPING PHARM INC |
MELOXICAM | MELOXICAM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 217579 | ASCENT PHARMS 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 | 077882 | COREPHARMA |
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 PHARMS LTD |
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 |
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 | 077920 | AIPING PHARM INC |
MELOXICAM | MELOXICAM | 15MG | TABLET;ORAL | Prescription | No | AB | 217579 | ASCENT PHARMS 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 | 077882 | COREPHARMA |
MELOXICAM | MELOXICAM | 15MG | TABLET;ORAL | Prescription | No | AB | 077931 | DR REDDYS LABS INC |
MELOXICAM | MELOXICAM | 15MG | TABLET;ORAL | Prescription | No | AB | 077932 | GLENMARK PHARMS LTD |
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 |