Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077918
Company: YUNG SHIN PHARM

Products on ANDA 077918

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 077918

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/07/2006	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
12/23/2024	SUPPL-10	Labeling-Container/Carton Labels		Label is not available on this site.
11/21/2024	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/29/2024	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/22/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/22/2019	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/12/2013	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/10/2010	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
09/24/2009	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
05/27/2009	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077918

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