Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209487
Company: LUPIN LTD

Products on ANDA 209487

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MELOXICAM	MELOXICAM	5MG	CAPSULE;ORAL	Prescription	AB	No	No
MELOXICAM	MELOXICAM	10MG	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209487

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209487Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/27/2022	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 209487

MELOXICAM

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MELOXICAM	MELOXICAM	5MG	CAPSULE;ORAL	Prescription	No	AB	209487	LUPIN LTD
MELOXICAM	MELOXICAM	5MG	CAPSULE;ORAL	Prescription	No	AB	211398	NOVITIUM PHARMA

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MELOXICAM	MELOXICAM	10MG	CAPSULE;ORAL	Prescription	No	AB	209487	LUPIN LTD
MELOXICAM	MELOXICAM	10MG	CAPSULE;ORAL	Prescription	No	AB	211398	NOVITIUM PHARMA