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TRANDATE

NDA

LABETALOL HYDROCHLORIDE | N018716 | ALVOGEN INC

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 2 - US RLD Pack Insert of TRANDATE from Drugs@FDA (SUPPL-21 dated ... FDA-2023-P-4552 · 7 docket documents Nines Consult Pharma, LLC filed a suitability petition regarding Trandate (labetalol hydrochloride), referencing the US reference listed drug pack insert from a November 2010 FDA supplement to support their petition for regulatory determination of suitability for ANDA purposes.	Suitability	2023-10-17	Denied	Nines Consult Pharma, LLC
Citizen Petition from Macleods Pharmaceuticals Limited FDA-2022-P-2768 · 3 docket documents Macleods Pharmaceuticals Limited submitted this citizen petition on November 4, 2022, requesting that the FDA determine whether the reference listed drug Trandate (Labetalol hydrochloride) tablets, 100 mg strength, listed under NDA N018716, was withdrawn from commercial distribution for reasons othe	Other	2022-11-04	Denied	Macleods Pharmaceuticals Limited
J R Rapoza Associates, Inc. - Citizen Petition FDA-2010-P-0326 · 4 docket documents JR Rapoza Associates, Inc. filed this citizen petition under 21 CFR 10.25(a) and 10.30 requesting that the FDA Commissioner determine whether Labetalol Hydrochloride oral tablets, 300mg (Trandate, NDA N018716, Prometheus Labs) was withdrawn from commercial distribution for reasons other than safety	Other	2010-06-30	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

31 trials from ClinicalTrials.gov, 1 active, 20 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Preeclampsia Postpartum Antihypertensive Treatment NCT04298034	Phase 3	Active	Medical College of Wisconsin	300	2020-07-17 → 2025-12-30
Effects of Labetalol on Human Cocaine Use - 8 NCT00000291	Phase 2	Completed	National Institute on Drug Abuse (NIDA)	—	1997-10 → 2001-12
Oral Nifedipine Versus Oral Labetalol NCT02168309	N/A	Completed	Cedars-Sinai Medical Center	50	2014-06 → 2016-05
Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department NCT00765648	Phase 4	Completed	The Cleveland Clinic	226	2008-10 → 2010-01
Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy NCT01912677	Phase 4	Completed	Gynuity Health Projects	894	2015-04 → 2017-12
Esmolol vs. Labetalol in Endoscopic Sinus Surgery NCT03661346	Phase 2	Completed	The University of Texas Medical Branch, Galveston	28	2017-03-01 → 2018-03-30
Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial NCT00963976	Phase 2	Completed	University of Alberta	74	2007-01 → 2012-02
The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial NCT00716079	N/A	Completed	The George Institute	2,839	2008-09 → 2012-12
Response to Anti-hypertensives in Pregnant and Postpartum Patients NCT03506724	Phase 4	Completed	Icahn School of Medicine at Mount Sinai	109	2017-09-11 → 2019-04-05
Perfusion and Antihypertensive Therapy in Acute Ischemic Stroke NCT02327793	Phase 2	Completed	University of Alberta	65	2009-06 → 2015-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain13 active DMFs6 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

OLON SPALABETALOL HYDROCHLORIDE

DMF 117791995

CAMBREX PROFARMACO MILANO SRLLABETALOL HYDROCHLORIDE

DMF 127581997

COSMA SPALABETALOL HYDROCHLORIDE

DMF 147022000

FLAMMA SPALABETALOL HYDROCHLORIDE

DMF 163142002

SOLARA ACTIVE PHARMA SCIENCES LTDLABETALOL HYDROCHLORIDE

DMF 237102010

NEULAND LABORATORIES LTDLABETALOL HYDROCHLORIDE USP

DMF 305642016

UNICHEM LABORATORIES LTDLABETALOL HYDROCHLORIDE USP

DMF 315842017

SRINI PHARMACEUTICALS PRIVATE LTDLABETALOL HYDROCHLORIDE USP

DMF 340732019

MACLEODS PHARMACEUTICALS LTDLABETALOL HYDROCHLORIDE USP

DMF 340992020

PHLOW CORPLABETALOL HYDROCHLORIDE

DMF 352332021

VIYASH LIFE SCIENCES PRIVATE LTDLABETALOL HYDROCHLORIDE USP

DMF 373062022

ZYDUS LIFESCIENCES LTDLABETALOL HYDROCHLORIDE USP

DMF 378562022

ALIVUS LIFE SCIENCES LTDLABETALOL HYDROCHLORIDE USP

DMF 380642023

GLAXOCHEM LTDInactiveLABETALOL HYDROCHLORIDE

DMF 57151985

SIBEFAT SPAInactiveLABETALOL HYDROCHLORIDE

DMF 84951990

ERREGIERRE SPAInactiveLABETALOL HYDROCHLORIDE

DMF 99271992

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveLABETALOL HYDROCHLORIDE

DMF 109011994

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveLABETALOL HYDROCHLORIDE

DMF 173192004

MYLAN LABORATORIES LTDInactiveLABETALOL HYDROCHLORIDE USP

DMF 193662006

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Apr 26, 2024	SUPPL -36	View Letter (PDF)
Feb 14, 2023	SUPPL -28	View Letter (PDF)
Nov 30, 2010	SUPPL -26	View Letter (PDF)
May 29, 2003	SUPPL -23	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 24, 1985

No patent or exclusivity listings for this strength.

#002 — 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 1, 1984

#003 — 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 1, 1984

#004 — 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 1, 1984