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NDA

PHENTERMINE HYDROCHLORIDE | N012737 | SANDOZ CONSUMER HEALTH CARE GROUP DIV SANDOZ PHARMACEUTICALS CORP

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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.

Products (1)

#001 — 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.