PDF cover 0448.qxd DOLPHIN Current Patents Gazette Patenting in Context News & Highlights from Week 0448 The records appearing in this Gazette will be added to DOLPHIN, the database Of all pharmaceutical inventions in the next week.
author: LEmson
Drug Approvals - O Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Ocufen Ophthalmic Solution, (0.03%) Allergan NDA 19-404/S020 8/25/03 8/28/03 8/28/03 - Ocufen Ophthalmic Solution (0.03%) Allergan NDA 19-404/S017 8/17/01 - 4/15/03 - Ocufen Ophthalmic Solution (0.03%) Allergan NDA 19-404/S014 7/30/01 - 4/15/03 - Ofloxacin Injection, 40 mg/mL packaged in 10 mL...
Prescription and Over-the-Counter Drug Product List: 12/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA...
http://www.fda.gov/cder/orange/appendix_a.txt IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, BACITRACIN ZINC NEOSPORIN, GRAMICIDIN NEOSPORIN, NEOMYCIN SULFATE (OTC) NEOTHYLLINE, DYPHYLLINE NEOTRIZINE, TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE; SULFAMETHAZINE) NEPHRAMINE 5.4%, AMINO ACIDS NEPHROFLOW, IODOHIPPURATE SODIUM, I-123 NEPTAZANE, METHAZOLAMIDE NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE...
Prescription and OTC Drug Product List 2/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION; ORAL AUGMENTIN '400' -D- + GLAXOSMITHKLINE 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD -A- 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL ...
C:\Documents and Settings\cutrightd\My Documents\aNDA\Labeling\211\ 49\AP Ltr Ovidrel.doc DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 21- 149/ S- 006 Serono, IncOvidrel ® (choriogonadotropin alfa for...
author: Dale Cutright
C:\Documents and Settings\cutrightd\My Documents\aNDA\Labeling\211\ 49\AP Ltr Ovidrel.doc page 1
author: Dale Cutright
Serono Serono is one of the world’s top three biotechnology companies, with sales of USD 1.147 billion (2000) and invests more than 20% of its sales in R&D. They currently have over 30 projects that are in ...
CPMP Press Release 68th meeting February 2001 page 6 Press Release CPMP/ 521/ 01 6/ 15 ANNEX 3 to CPMP February 2001 Press Release Medicinal products granted a Community Marketing Authorisation under the Centralised Procedure since January 2001 Press Release Brand name Prandin INN replaglinide Marketing Authorisation Holder Novo Nordisk ATC code A10BX02 Indication ...
author: CPMP
subject: Press Release
http://www.fda.gov/cder/foi/label/2000/21149lbl.pdf Ovidrel ® (choriogonadotropin alfa) DRAFT Annotated Package Insert Item 2, pOvidrel O O 1 (choriogonadotropin alfa for injection) 2 FOR SUBCUTANEOUS USE 3 DESCRIPTION 4 Ovidrel ® (choriogonadotropin alfa for injection) is a sterile lyophilized powder composed of 5 choriogonadotropin ...
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