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METOLAZONE

ANDA

METOLAZONE | A076698 | MYLAN PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Zydus Pharmaceuticals (USA) Inc. FDA-2015-P-4946 Zydus Pharmaceuticals (USA) Inc. filed this citizen petition requesting that the FDA determine whether UCB Inc.'s ZAROXOLYN (metolazone) Tablets at 5 mg and 10 mg strengths, approved under NDA 017386, were voluntarily withdrawn for safety or effectiveness reasons. If the FDA determines the product w	505(q)	2015-12-23	Withdrawn	Zydus Pharmaceuticals (USA) Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain4 active DMFs6 inactive

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

SIEGFRIED EVIONNAZ SAMETOLAZONE

DMF 57481985

CENTAUR PHARMACEUTICALS PRIVATE LTDMETOLAZONE USP

DMF 303102016

BIOPHORE INDIA PHARMACEUTICALS PVT LTDMETOLAZONE USP

DMF 328682018

MSN LIFE SCIENCES PRIVATE LTDMETOLAZONE USP

DMF 336982019

EASTMAN KODAK COInactiveMETOLAZONE (ZAROXOLYN)

DMF 46551982

SUMIKA FINE CHEMICALS CO LTDInactiveMETOLAZONE

DMF 64381986

HEXAGON LABORATORIES INCInactiveMETOLAZONE

DMF 64871986

DIOSYNTH BVInactiveMETOLAZONE

DMF 75291988

HOECHST MARION ROUSSEL SAInactiveMETOLAZONE

DMF 84211990

XIAN LIBANG PHARMACEUTICAL CO LTDInactiveMETOLAZONE USP

DMF 160012002

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

Products (3)

Sort:

#001 — 2.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 23, 2003

No patent or exclusivity listings for this strength.

#002 — 5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 19, 2004

#003 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 19, 2004