An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075133
Company: WATSON LABS

Products on ANDA 075133

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075133

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/1998	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75133ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75133_Labetalol%20Hydrochloride.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/07/2007	SUPPL-11	Labeling		Label is not available on this site.
11/06/2002	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
06/06/2002	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
06/06/2002	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
02/20/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
09/19/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
08/31/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
07/07/1999	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075133

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

Top