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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076466
Company: SANDOZ

Products on ANDA 076466

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076466

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2003	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/076466Orig1s000BioeqR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/10/2011	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076466

METOLAZONE

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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