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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077921
Company: ZYDUS PHARMS USA

Products on ANDA 077921

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 077921

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/2006/077921s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/05/2023	SUPPL-34	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/15/2016	SUPPL-30	Labeling		Label is not available on this site.
08/15/2016	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
09/10/2015	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
09/10/2015	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
09/10/2015	SUPPL-17	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/26/2010	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
04/20/2016	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/26/2010	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
08/27/2010	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/03/2014	SUPPL-9	Labeling		Label is not available on this site.
09/23/2008	SUPPL-7	Labeling		Label is not available on this site.
11/20/2007	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077921

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	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 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	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 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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