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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216216
Company: NE RX PHARMA

Products on ANDA 216216

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METOLAZONE	METOLAZONE	2.5MG	TABLET;ORAL	Prescription	AB	No	No
METOLAZONE	METOLAZONE	5MG	TABLET;ORAL	Prescription	AB	No	No
METOLAZONE	METOLAZONE	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216216

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/25/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216216

METOLAZONE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METOLAZONE	METOLAZONE	2.5MG	TABLET;ORAL	Prescription	No	AB	213251	ALEMBIC
METOLAZONE	METOLAZONE	2.5MG	TABLET;ORAL	Prescription	No	AB	214799	BAYSHORE PHARMS LLC
METOLAZONE	METOLAZONE	2.5MG	TABLET;ORAL	Prescription	No	AB	213827	INNOGENIX
METOLAZONE	METOLAZONE	2.5MG	TABLET;ORAL	Prescription	No	AB	218606	LEADING
METOLAZONE	METOLAZONE	2.5MG	TABLET;ORAL	Prescription	No	AB	076698	MYLAN
METOLAZONE	METOLAZONE	2.5MG	TABLET;ORAL	Prescription	No	AB	216216	NE RX PHARMA
METOLAZONE	METOLAZONE	2.5MG	TABLET;ORAL	Prescription	No	AB	215616	RENATA
METOLAZONE	METOLAZONE	2.5MG	TABLET;ORAL	Prescription	No	AB	215184	RUBICON
METOLAZONE	METOLAZONE	2.5MG	TABLET;ORAL	Prescription	No	AB	076732	SANDOZ

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METOLAZONE	METOLAZONE	5MG	TABLET;ORAL	Prescription	No	AB	213251	ALEMBIC
METOLAZONE	METOLAZONE	5MG	TABLET;ORAL	Prescription	No	AB	214799	BAYSHORE PHARMS LLC
METOLAZONE	METOLAZONE	5MG	TABLET;ORAL	Prescription	No	AB	213827	INNOGENIX
METOLAZONE	METOLAZONE	5MG	TABLET;ORAL	Prescription	No	AB	218606	LEADING
METOLAZONE	METOLAZONE	5MG	TABLET;ORAL	Prescription	No	AB	076698	MYLAN
METOLAZONE	METOLAZONE	5MG	TABLET;ORAL	Prescription	No	AB	216216	NE RX PHARMA
METOLAZONE	METOLAZONE	5MG	TABLET;ORAL	Prescription	No	AB	215616	RENATA
METOLAZONE	METOLAZONE	5MG	TABLET;ORAL	Prescription	No	AB	215184	RUBICON
METOLAZONE	METOLAZONE	5MG	TABLET;ORAL	Prescription	No	AB	076466	SANDOZ

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METOLAZONE	METOLAZONE	10MG	TABLET;ORAL	Prescription	No	AB	213251	ALEMBIC
METOLAZONE	METOLAZONE	10MG	TABLET;ORAL	Prescription	No	AB	214799	BAYSHORE PHARMS LLC
METOLAZONE	METOLAZONE	10MG	TABLET;ORAL	Prescription	No	AB	213827	INNOGENIX
METOLAZONE	METOLAZONE	10MG	TABLET;ORAL	Prescription	No	AB	218606	LEADING
METOLAZONE	METOLAZONE	10MG	TABLET;ORAL	Prescription	No	AB	076698	MYLAN
METOLAZONE	METOLAZONE	10MG	TABLET;ORAL	Prescription	No	AB	216216	NE RX PHARMA
METOLAZONE	METOLAZONE	10MG	TABLET;ORAL	Prescription	No	AB	215616	RENATA
METOLAZONE	METOLAZONE	10MG	TABLET;ORAL	Prescription	No	AB	215184	RUBICON
METOLAZONE	METOLAZONE	10MG	TABLET;ORAL	Prescription	No	AB	076466	SANDOZ

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