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ZONISAMIDE

ANDA

ZONISAMIDE | A077644 | UPSHER SMITH LABORATORIES LLC

3 strengths0 unique patents0 unique exclusivities

API Supply Chain13 active DMFs8 inactive

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

SUMITOMO PHARMA CO LTDZONISAMIDE DRUG SUBSTANCE

DMF 121981996

DIPHARMA FRANCIS SRLZONISAMIDE

DMF 173032004

ALIVUS LIFE SCIENCES LTDZONISAMIDE

DMF 179452004

WOCKHARDT LTDZONISAMIDE USP

DMF 180592005

SUN PHARMACEUTICAL INDUSTRIES LTDZONISAMIDE USP

DMF 181912005

ZYDUS LIFESCIENCES LTDZONISAMIDE

DMF 182072005

HETERO LABS LTDZONISAMIDE

DMF 184882005

MAITHRI DRUGS PRIVATE LTDZONISAMIDE USP

DMF 310092016

COHANCE LIFESCIENCES LTDZONISAMIDE USP

DMF 312982017

ALIVUS LIFE SCIENCES LTDZONISAMIDE USP (D270 PROCESS)

DMF 319732017

COHANCE LIFESCIENCES LTDZONISAMIDE USP

DMF 332562018

EMNAR PHARMA PRIVATE LTDZONISAMIDE USP

DMF 385242023

UNICHEM LABORATORIES LTDZONISAMIDE USP

DMF 402932024

PERRIGO API LTDInactiveZONISAMIDE

DMF 170272003

PROCOS SPAInactiveZONISAMIDE

DMF 172542004

JUZEN CHEMICAL CORPInactiveZONISAMIDE

DMF 176612004

MYLAN LABORATORIES LTDInactiveZONISAMIDE

DMF 179752005

DR REDDYS LABORATORIES LTDInactiveZONISAMIDE

DMF 181032005

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveZONISAMIDE

DMF 181972005

APOTEX PHARMACHEM INCInactiveZONISAMIDE

DMF 182032005

BACHEM SAInactiveZONISAMIDE

DMF 222762008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 28, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 22, 2005

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 22, 2005

#003 — 100MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 22, 2005