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LABETALOL HYDROCHLORIDE IN DEXTROSE

NDA

LABETALOL HYDROCHLORIDE | N213330 | HIKMA PHARMACEUTICALS USA INC

6 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Boehringer Ingelheim Pharmaceuticals Inc. et al v. InvaGen Pharmaceuticals, Inc. 1:2018cv01788 1 patentANDA 213330empagliflozin	D. Del.	2018-11-13	Terminated 2023-09-12	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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
Aug 20, 2024	SUPPL -6	View Letter (PDF)
Jun 16, 2023	SUPPL -5	View Letter (PDF)
Mar 28, 2023	SUPPL -3	View Letter (PDF)
Nov 10, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#005 — 10MG/2ML (5MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Mar 18, 2022

#006 — 20MG/4ML (5MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Aug 19, 2024

#001 — 200MG/200ML (1MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Nov 9, 2020

No patent or exclusivity listings for this strength.

#002 — 100MG/100ML (1MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Nov 9, 2020

#003 — 200MG/200ML (1MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Nov 9, 2020

#004 — 300MG/300ML (1MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Nov 9, 2020