Viewing data from:

PALONOSETRON HYDROCHLORIDE

ANDA

PALONOSETRON HYDROCHLORIDE | A208789 | INGENUS PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain15 active DMFs5 inactive

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

HAS HEALTHCARE ADVANCED SYNTHESIS SAPALONOSETRON HYDROCHLORIDE USP

DMF 160632002

NEULAND LABORATORIES LTDPALONOSETRON HYDROCHLORIDE

DMF 211232007

ALP PHARM BEIJING CO LTDPALONOSETRON HYDROCHLORIDE

DMF 232092009

TAPI NL BVPALONOSETRON HYDROCHLORIDE

DMF 233322009

DR REDDYS LABORATORIES LTDPALONOSETRON HYDROCHLORIDE USP

DMF 235902010

ROLABO OUTSOURCING SLPALONOSETRON HYDROCHLORIDE

DMF 244972010

QILU PHARMACEUTICAL CO LTDPALONOSETRON HYDROCHLORIDE USP (NON STERILE API)

DMF 246612011

EMCURE PHARMACEUTICALS LTDPALONOSETRON HYDROCHLORIDE USP

DMF 247842011

WAVELENGTH ENTERPRISES LTDPALONOSETRON HYDROCHLORIDE

DMF 247982011

APITORIA PHARMA PRIVATE LTDPALONOSETRON HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE)

DMF 259762012

MSN LABORATORIES PRIVATE LTDPALONOSETRON HYDROCHLORIDE USP [ROUTE CODE PI]

DMF 267842013

CIPLA LTDPALONOSETRON HYDROCHLORIDE USP

DMF 275282013

USV PRIVATE LTDPALONOSETRON HYDROCHLORIDE

DMF 280882015

TYCHE INDUSTRIES LTDPALONOSETRON HYDROCHLORIDE

DMF 293302015

WOCKHARDT BIO AGPALONOSETRON HYDROCHLORIDE USP

DMF 309552016

CATALENT PHARMA SOLUTIONS LLCInactivePALONOSETRON HYDROCHLORIDE 0.50 MG SOFTGELS

DMF 181872005

GLENMARK PHARMACEUTICALS LTDInactivePALONOSETRON HYDROCHLORIDE

DMF 243512010

RANBAXY LABORATORIES LTDInactivePALONOSETRON HYDROCHLORIDE

DMF 244482010

LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTDInactivePALONOSETRON HYDROCHLORIDE

DMF 265612012

KYONGBO PHARMACEUTICAL CO LTDInactivePALONOSETRON HYDROCHLORIDE

DMF 336132019

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

Products (1)

#001 — EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: May 22, 2020

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Applicant for Palonosetron Hydrochloride (NDA 208789) changed from Novast Labs to Ingenus Pharms LLC.

Old: NOVAST LABS

New: INGENUS PHARMS LLC

MODIFIEDApplicant Full Name7/1/2026

INGENUS PHARMACEUTICALS LLC replaced NOVAST LABORATORIES LTD as the applicant for palonosetron hydrochloride (NDA 208789).

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC