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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209603
Company: APPCO

Products on ANDA 209603

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	AB	No	No
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	AB	No	No
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	AB	No	No
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	400MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209603

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/20/2018	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
10/18/2024	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209603

LABETALOL HYDROCHLORIDE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	075113	AIPING PHARM INC
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	075215	ANDAS 5 HOLDING
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	209603	APPCO
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	211325	CADILA PHARMS LTD
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	212990	EPIC PHARMA LLC
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	074787	HERITAGE PHARMA
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	207863	HIBROW HLTHCARE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	217949	MACLEODS PHARMS LTD
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	200908	PH HEALTH
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	211953	RUBICON RESEARCH
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	075133	WATSON LABS
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	207743	ZYDUS PHARMS

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	075113	AIPING PHARM INC
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	075215	ANDAS 5 HOLDING
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	209603	APPCO
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	211325	CADILA PHARMS LTD
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	212990	EPIC PHARMA LLC
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	074787	HERITAGE PHARMA
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	207863	HIBROW HLTHCARE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	217949	MACLEODS PHARMS LTD
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	200908	PH HEALTH
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	211953	RUBICON RESEARCH
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	075133	WATSON LABS
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	207743	ZYDUS PHARMS

TABLET;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	075113	AIPING PHARM INC
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	075215	ANDAS 5 HOLDING
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	209603	APPCO
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	211325	CADILA PHARMS LTD
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	212990	EPIC PHARMA LLC
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	074787	HERITAGE PHARMA
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	207863	HIBROW HLTHCARE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	217949	MACLEODS PHARMS LTD
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	200908	PH HEALTH
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	211953	RUBICON RESEARCH
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	075133	WATSON LABS
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	207743	ZYDUS PHARMS

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