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Page 1: Proprietary Name Review(s)
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125418Orig1s000 - Food and Drug Administration...125418Orig1s000 PROPRIETARY NAME REVIEW(S) 4 of 4 ... Stedman's Medical Dictionary, 26th ed. 1995, at 1292. Reference ID: 3165699 (b)

210737Orig1s000 210737Orig2s000 PROPRIETARY NAME ......Thus, Cumberland Pharmaceuticals Inc. resubmitted the proposed proprietary name, RediTrex, for review. 2 METHODS AND DISCUSSION

206334Orig1s000 · 2014-03-03  · This review evaluates the proposed proprietary name, Orbactiv, from a safety and promotional perspective. The sources and methods used to evaluate

Kadcyla proprietary name review

Copyright © 2002-2005 AirDefense Proprietary and Confidential. Name Title Contact information

International non-proprietary name: USTEKINUMAB · PDF fileInternational non-proprietary name: USTEKINUMAB Procedure No. EMEA/H/C/000958/II/0029 Note Variation assessment report as

Bortezomib Hospira International non-proprietary name ... · Committee for Medicinal Products for Human Use (CHMP) Assessment report . Bortezomib Hospira . International non-proprietary

International non-proprietary name: apalutamide Procedure No. … · International non-proprietary name: apalutamide . Procedure No. EMEA/H/C/004452/II/0001 . Marketing authorisation

APPLICATION NUMBER: 21-983 PROPRIETARY NAME REVIEW(S)€¦ · APPLICATION NUMBER: 21-983 PROPRIETARY NAME REVIEW(S) FOOD AND DRUG ADMINISTRATION Center for Drug Evaluation and Research

022458Orig1s000 - Food and Drug Administration · center for drug evaluation and research application number: 022458orig1s000 proprietary name review(s)

Proprietary Name Review(s) · 2019. 12. 4. · review on December 14, 2018. 1.2 PRODUCT INFORMATION The following product information is provided in the proprietary name submission

022399Orig1s000 - Food and Drug Administration PROPRIETARY NAME REVIEW(S) Department of Health and Human Services Food and Drug Administration ... OSE Regulatory Project Manager, at

Guide to Online International Non-Proprietary Name (INN) Electronic Name Submission Process

PROPRIETARY NAME REVIEW(S)Mar 22, 2010  · Applicant’s intended pronunciation of the proprietary name (i sop ‘to kar pen) was provided and taken into consideration. 2.2 MEDICATION

PROPRIETARY NAME AND DOSAGE FORM

SEC Regulation SCI Automation Review Compliance January 2015 Proprietary

Report on the Deliberation Results Non-proprietary Name

International Non-proprietary Name: bazedoxifene Procedure No

Novo Nordisk's Victoza FDA CDER Proprietary Name Review

204427Orig1s000 - Food and Drug Administration · center for drug evaluation and research application number: 204427orig1s000 proprietary name review(s)

Janage proprietary drug name personality profile-2

Doc Name – 1 Telcordia Technologies Proprietary - Internal use only. See proprietary restrictions on title page. The Scholars BALD heads forgetful of

LIST OF PROPRIETARY FIRMS WITH NEW … · LIST OF PROPRIETARY FIRMS WITH NEW REGISTRATION NUMBER. MEMBER NO NAME FIRM NAME NEW REGNNO 8407 Bibhuti Bhusan Nath B …

International Non-proprietary Name: Imipenem monohydrate

Report on the Deliberation Results4 Review Report (1) June 28, 2013 I. Product Submitted for Registration [Brand name] Vyndaqel Capsules 20 mg [Non-proprietary name] Tafamidis Meglumine

Proprietary Name Review(s) - Food and Drug Administration · Suffixes submitted by Samsung*** 1. 2. bwwd 3. We reviewed Samsung’s proposed suffixes in order of preference listed

International non-proprietary name: solriamfetol Procedure

proprietary name review(s) - Accessdata FDA - Food and Drug

PDUFA Pilot Project: Proprietary Name Review · PDF fileConcept Paper PDUFA Pilot Project Proprietary Name Review I. INTRODUCTION On September 27, 2007, President Bush signed into

CLINICAL REVIEW · 2020. 5. 14. · Nonproprietary Name Filgrastim.aafi (referred to as “PF-06881893” by the applicant)* Trade Name Nivestym (proprietary, conditionally acceptable)

Kadcyla FDA Proprietary Name Review

PROPRIETARY NAME REVIEW(S) · 2.2.1 United States Adopted Names (USAN) Search There is no USAN stem present in the proposed proprietary name.4 2.2.2 Components of the Proposed Proprietary

SCHEDULING STATUS PROPRIETARY NAME AND DOSAGE FORM …€¦ · 08-04-2020  · PROPRIETARY NAME AND DOSAGE FORM . BOTOX® vacuum-dried injection. COMPOSITION . BOTOX® (Botulinum

PDUFA PILOT PROJECT PROPRIETARY NAME REVIEW/media/Images... ·  · 2011-06-26PDUFA PILOT PROJECT PROPRIETARY NAME REVIEW ... the Center for Drug Evaluation and Research (CDER)

Proprietary Name Review(s)...2019/02/19  · 2.2.8 Communication of DMEPA’s Analysis at Midpoint of Review DMEPA communicated our findings to the Division of Oncology Products 2