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NDA

GRANISETRON HYDROCHLORIDE | N021238 | HOFFMANN LA ROCHE INC

1 strength0 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.

WAVELENGTH ENTERPRISES LTDGRANISETRON HYDROCHLORIDE

DMF 138441998

CHONGQING CARELIFE PHARMACEUTICAL CO LTDGRANISETRON HYDROCHLORIDE USP NON-STERILE BULK DRUG SUBSTANCE

DMF 168382003

INKE SAGRANISETRON HYDROCHLORIDE

DMF 173462004

CIPLA LTDGRANISETRON HYDROCHLORIDE USP

DMF 177932004

NATCO PHARMA LTDGRANISETRON HYDROCHLORIDE

DMF 192152006

HUBEI HAOSUN PHARMACEUTICAL CO LTDGRANISETRON HYDROCHLORIDE (NON-STERILE)

DMF 193652006

WOCKHARDT LTDGRANISETRON HYDROCHLORIDE

DMF 197082006

TARO PHARMACEUTICAL INDUSTRIES LTDGRANISETRON HYDROCHLORIDE USP

DMF 199472006

ORBION PHARMACEUTICALS PRIVATE LTDGRANISETRON HYDROCHLORIDE

DMF 199672006

NATCO PHARMA LTDGRANISETRON HYDROCHLORIDE (INJECTABLE GRADE)

DMF 206782007

SCINOPHARM TAIWAN LTDGRANISETRON HYDROCHLORIDE

DMF 208692007

HIKMA PHARMACEUTICALSGRANISETRON HYDROCHLORIDE USP

DMF 252982011

SYN-TECH CHEM AND PHARM CO LTDGRANISETRON HYDROCHLORIDE USP

DMF 265042012

SWATI SPENTOSE PRIVATE LTDGRANISETRON HYDROCHLORIDE USP

DMF 351472020

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveGRANISETRON HYDROCHLORIDE USP

DMF 165602003

AMINO CHEMICALS LTDInactiveGRANISETRON HYDROCHLORIDE

DMF 174762004

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveGRANISETRON HYDROCHLORIDE

DMF 184262005

MYLAN LABORATORIES LTDInactiveGRANISETRON HYDROCHLORIDE

DMF 190702005

HAMARI CHEMICALS LTDInactiveGRANISETRON HYDROCHLORIDE

DMF 235882010

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Nov 12, 2009	SUPPL -7	View Letter (PDF)
Nov 30, 2005	SUPPL -5	View Letter (PDF)
Jun 27, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 2MG BASE/10ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Jun 27, 2001

No patent or exclusivity listings for this strength.