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VINORELBINE TARTRATE

ANDA

VINORELBINE TARTRATE | A208997 | INGENUS PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs8 inactive

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

PIERRE FABRE MEDICAMENTVINORELBINE TARTRATE

DMF 94771991

MINAKEM HIGH POTENTVINORELBINE TARTRATE

DMF 146191999

HUBEI HONCH PHARMACEUTICAL CO LTDVINORELBINE TARTRATE

DMF 260912013

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveVINORELBINE TARTRATE USP

DMF 159562002

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDInactiveVINORELBINE TARTRATE USP

DMF 160112002

EXOPHARM CO LTDInactiveVINORELBINE TARTRATE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 190942006

CIPLA LTDInactiveVINORELBINE TARTRATE USP

DMF 201582009

SYNBIAS PHARMA LTDInactiveVINORELBINE TARTRATE

DMF 219292008

ALP PHARM BEIJING CO LTDInactiveVINORELBINE TARTRATE

DMF 239512010

QILU PHARMACEUTICAL CO LTDInactiveVINORELBINE TARTRATE (PROCESS I) (NON STERILE, API)

DMF 252032011

SYNBIAS PHARMA AGInactiveVINORELBINE TARTRATE

DMF 282212014

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

Products (1)

#001 — EQ 10MG BASE/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Aug 5, 2019

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Applicant for Vinorelbine Tartrate (NDA 208997) 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 Vinorelbine Tartrate (NDA 208997).

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC