Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077927
Company: UNICHEM

Products on ANDA 077927

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 077927

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2006	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/10/2024	SUPPL-44	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/22/2019	SUPPL-26	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/02/2015	SUPPL-17	Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
06/13/2013	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/31/2011	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/03/2011	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/21/2009	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077927

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	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	077920	SCIEGEN PHARMS INC
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	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	077920	SCIEGEN PHARMS INC
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