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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202870
Company: ALEMBIC

Products on ANDA 202870

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;50MG	TABLET;ORAL	Prescription	AB	No	No
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;100MG	TABLET;ORAL	Prescription	AB	No	Yes
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	50MG;100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202870

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/06/2013	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
05/26/2023	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
05/26/2023	SUPPL-15	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202870

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 25MG;50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOPRESSOR HCT	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;50MG	TABLET;ORAL	Prescription	Yes	AB	018303	VALIDUS PHARMS
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;50MG	TABLET;ORAL	Prescription	No	AB	202870	ALEMBIC
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;50MG	TABLET;ORAL	Prescription	No	AB	076792	MYLAN
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;50MG	TABLET;ORAL	Prescription	No	AB	090654	SUN PHARM INDS

TABLET;ORAL; 25MG;100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;100MG	TABLET;ORAL	Prescription	No	AB	202870	ALEMBIC
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;100MG	TABLET;ORAL	Prescription	No	AB	076792	MYLAN
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;100MG	TABLET;ORAL	Prescription	No	AB	090654	SUN PHARM INDS

TABLET;ORAL; 50MG;100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	50MG;100MG	TABLET;ORAL	Prescription	No	AB	202870	ALEMBIC
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	50MG;100MG	TABLET;ORAL	Prescription	No	AB	076792	MYLAN
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	50MG;100MG	TABLET;ORAL	Prescription	No	AB	090654	SUN PHARM INDS

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