Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077932
Company: GLENMARK PHARMS LTD

Products on ANDA 077932

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077932

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
11/21/2024	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
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-Package Insert, Labeling-Medication Guide		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.

Therapeutic Equivalents for ANDA 077932

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	077932	GLENMARK PHARMS LTD
MELOXICAM	MELOXICAM	7.5MG	TABLET;ORAL	Prescription	No	AB	077928	NOVITIUM PHARMA
MELOXICAM	MELOXICAM	7.5MG	TABLET;ORAL	Prescription	No	AB	077938	PURACAP PHARM
MELOXICAM	MELOXICAM	7.5MG	TABLET;ORAL	Prescription	No	AB	077931	RISING
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	077932	GLENMARK PHARMS LTD
MELOXICAM	MELOXICAM	15MG	TABLET;ORAL	Prescription	No	AB	077928	NOVITIUM PHARMA
MELOXICAM	MELOXICAM	15MG	TABLET;ORAL	Prescription	No	AB	077938	PURACAP PHARM
MELOXICAM	MELOXICAM	15MG	TABLET;ORAL	Prescription	No	AB	077931	RISING
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