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APRESOLINE

NDA

HYDRALAZINE HYDROCHLORIDE | N008303 | NOVARTIS PHARMACEUTICALS CORP

5 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain14 active DMFs5 inactive

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

SUMITOMO CHEMICAL CO LTDHYDRALAZINE HYDROCHLORIDE

DMF 24211975

NAVINTA LLCHYDRALAZINE HYDROCHLORIDE USP

DMF 199042006

HETERO LABS LTDHYDRALAZINE HYDROCHLORIDE

DMF 205202007

ARCHIMICA SPAHYDRALAZINE HYDROCHLORIDE

DMF 221692008

SOLARA ACTIVE PHARMA SCIENCES LTDHYDRALAZINE HYDROCHLORIDE USP

DMF 226332009

NAVINTA LLCHYDRALAZINE HYDROCHLORIDE USP (P) GRADE

DMF 243212010

MACLEODS PHARMACEUTICALS LTDHYDRALAZINE HYDROCHLORIDE

DMF 303542016

APITORIA PHARMA PRIVATE LTDHYDRALAZINE HYDROCHLORIDE USP

DMF 320192017

WANBURY LTDHYDRALAZINE HYDROCHLORIDE

DMF 331292018

UNICHEM LABORATORIES LTDHYDRALAZINE HYDROCHLORIDE USP

DMF 343552020

COHANCE LIFESCIENCES LTDHYDRALAZINE HYDROCHLORIDE USP

DMF 344522019

CADILA PHARMACEUTICALS LTDHYDRALAZINE HYDROCHLORIDE USP

DMF 349452020

ALIVUS LIFE SCIENCES LTDHYDRALAZINE HYDROCHLORIDE USP

DMF 358072021

AMI LIFESCIENCES PRIVATE LTDHYDRALAZINE HYDROCHLORIDE

DMF 416462025

DAIWA PHARMACEUTICAL CO LTDInactiveHYDRALAZINE HYDROCHLORIDE

DMF 56111984

SIEGFRIED AGInactiveHYDRALAZINE HYDROCHLORIDE

DMF 57201985

SHANDONG WEIFANG PHARMACEUTICAL FACTORY CO LTDInactiveHYDRALAZINE HYDROCHLORIDE (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 192092006

DK PHARMA CHEM PVT LTDInactiveHYDRALAZINE HYDROCHLORIDE USP

DMF 219532008

EUTICALS SPAInactiveHYDRALAZINE HYDROCHLORIDE INJECTABLE GRADE

DMF 226822009

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

Products (5)

Sort:

#001 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#004 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#005 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982