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PHENTERMINE HYDROCHLORIDE

ANDA

PHENTERMINE HYDROCHLORIDE | A204663 | ZYDUS PHARMACEUTICALS USA INC

3 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ALPEX PHARMA, S.A. et al v. ZYDUS PHARMACEUTICALS USA, INC. et al 1:2013cv04076 1 patentANDA 204663phentermine hydrochloride	D.N.J.	2013-07-01	Terminated 2013-10-16	—

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

API Supply Chain6 active DMFs3 inactive

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

SIEGFRIED USA LLCPHENTERMINE HYDROCHLORIDE USP

DMF 34321979

OLON SPAPHENTERMINE HYDROCHLORIDE

DMF 152892001

CHEMISCHE FABRIK BERG GMBHPHENTERMINE HYDROCHLORIDE USP

DMF 154422001

SYMED LABS LTDPHENTERMINE HYDROCHLORIDE

DMF 248562011

ZYDUS LIFESCIENCES LTDPHENTERMINE HYDROCHLORIDE USP

DMF 261452012

MALLADI DRUGS AND PHARMACEUTICALS LTDPHENTERMINE HYDROCHLORIDE

DMF 386572023

TROPONWERKE GMBH CO KGInactivePHENTERMINE (C.A. NAME,-DIMETHYLPHENETHYLAMINE)

DMF 12141968

CAMBREX CHARLES CITY INCInactivePHENTERMINE HYDROCHLORIDE

DMF 154612001

CODY LABORATORIES INC A WHOLLY OWNED SUBSIDIARY OF LANNETT CO INCInactivePHENTERMINE HYDROCHLORIDE ACTIVE INGREDIENT

DMF 159402002

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 30, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 15MG

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jun 28, 2017

No patent or exclusivity listings for this strength.

#002 — 30MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jun 28, 2017

#003 — 37.5MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jun 28, 2017