Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211398
Company: NOVITIUM PHARMA

Products on ANDA 211398

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211398

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/11/2022	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211398

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