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POSACONAZOLE

ANDA

POSACONAZOLE | A211500 | MYLAN LABORATORIES LTD

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
MERCK SHARP & DOHME CORP. v. MYLAN LABORATORIES LIMITED 2:2018cv01334 2 patentsANDA 211500posaconazole	E.D. Pa.	2018-03-29	Terminated 2018-05-21	—

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

API Supply Chain29 active DMFs1 inactive

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

OLON SPAPOSACONAZOLE

DMF 243462010

MSN LABORATORIES PRIVATE LTDPOSACONAZOLE AMORPHOUS [ROUTE CODE PKA]

DMF 276142013

MSN LABORATORIES PRIVATE LTDPOSACONAZOLE (FORM-I) [ROUTE CODE - "PJ1"]

DMF 277202013

ALP PHARM BEIJING CO LTDPOSACONAZOLE FOMR I

DMF 282232017

WUHAN ZY PHARMACEUTICAL CO LTDPOSACONAZOLE

DMF 283862014

NEULAND LABORATORIES LTDPOSACONAZOLE

DMF 288262018

WUHAN ZY PHARMACEUTICAL CO LTDPOSACONAZOLE FORM 1

DMF 292282015

MSN LABORATORIES PRIVATE LTDPOSACONAZOLE AMORPHOUS (PROCESS-2) [ROUTE CODE - "PKA"]

DMF 293492015

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDPOSACONAZOLE

DMF 297312016

APOTEX INCPOSACONAZOLE

DMF 303432016

JIANGSU HANSYN PHARMACEUTICAL CO LTDPOSACONAZOLE FORM I

DMF 308592016

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDPOSACONAZOLE CRYSTALLINE III

DMF 308862016

SOLARA ACTIVE PHARMA SCIENCES LTDPOSACONAZOLE FORM-1

DMF 315772017

DR REDDYS LABORATORIES LTDPOSACONAZOLE

DMF 320982017

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDPOSACONAZOLE CRYSTALLINE I (NON-STERILE, API)

DMF 323462017

BIOCON LTDPOSACONAZOLE

DMF 325242018

HONOUR LAB LTDPOSACONAZOLE (FORM-I)

DMF 329732018

COHANCE LIFESCIENCES LTDPOSACONAZOLE

DMF 344512019

QUIMICA SINTETICA SAPOSACONAZOLE

DMF 354402020

METROCHEM API PRIVATE LTDPOSACONAZOLE

DMF 355172021

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDPOSACONAZOLE FORM I

DMF 361162021

BIOCON LTDPOSACONAZOLE

DMF 366882022

METROCHEM API PRIVATE LTDPOSACONAZOLE (FORM I)

DMF 369692022

SHANDONG JINCHENG KUNLUN PHARMACEUTICAL CO LTDPOSACONAZOLE

DMF 377342022

CHROMO LABORATORIES INDIA PRIVATE LTDPOSACONAZOLE

DMF 407312025

WEINAN MANARECO PHARMACEUTICAL CO LTDPOSACONAZOLE

DMF 407682024

CHONGQING HUAPONT SHENGCHEM PHARMACEUTICAL CO LTDPOSACONAZOLE

DMF 409592024

SICHUAN KELUN PHARMACEUTICAL CO LTDPOSACONAZOLE

DMF 417682025

BIOCON LTDPOSACONAZOLE (FORM-1)

DMF 424092025

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDInactivePOSACONAZOLE (NON STERILE API)

DMF 283142014

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 13, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG/16.7ML (18MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Dec 26, 2023

No patent or exclusivity listings for this strength.