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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075113
Company: SANDOZ

Products on ANDA 075113

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	Yes
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075113

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/04/1998	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75113ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/25/2015	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
09/28/2010	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
12/20/2002	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
12/20/2002	SUPPL-5	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
11/29/2001	SUPPL-4	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
11/29/2001	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
02/02/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
04/30/1999	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075113

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	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	207863	EYWA
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	074787	HERITAGE PHARMA
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	075215	INNOGENIX
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	200908	PAR FORM
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	211953	RUBICON
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	075113	SANDOZ
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	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	207863	EYWA
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	074787	HERITAGE PHARMA
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	075215	INNOGENIX
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	200908	PAR FORM
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	211953	RUBICON
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	075113	SANDOZ
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	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	207863	EYWA
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	074787	HERITAGE PHARMA
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	075215	INNOGENIX
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	200908	PAR FORM
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	211953	RUBICON
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	075113	SANDOZ
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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