Database C C - investigational drugs, therapies and vaccines # - A - B - C - D - E - F - G - H - I - J - K - L - M - N - O - P - Q - R - S - T - U - V - W - X - Y - Z From this page you may order documents with information covering investigational products.
Database O O - investigational drugs, therapies and vaccines # - A - B - C - D - E - F - G - H - I - J - K - L - M - N - O - P - Q - R - S - T - U - V - W - X - Y - Z From this page you may order documents with information covering investigational products To purchase documents on-line click on- -link attached to selected document!- The fee is $15 per document Documents are delivered by e-mail...
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...
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW- TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION ANASTROZOLE ASTRAZENECA 20-541 SE1 010 5-Mar-02 5-Sep-02 Y 6.0 Provides for the use of ARIMIDEX ...
author: Darlene Norris
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...
Document Information Page DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 NDA 21- 142/ S- 010 Connetics Corporation Attention: Sharon LOlux ...
author: CDER.USER
Document Information Page page 2
author: CDER.USER
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author: CDER.USER
Document Information Page DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 1 NDA 21 142/ S- 009 Connetics CorpOlux ® (clobetasol ...
author: KALYANI BHATT/REGULATORY PROJECT MANGER
Document Information Page page 1
author: KALYANI BHATT/REGULATORY PROJECT MANGER
Approved Biotechnology Drugs, 2000 Biotechnology Information, Advocacy and Business Support | About Us | BIO Events | BIO Members | Join BIO | Member Services | Links | Home CMS Payment System Prescription Coverage & Reimbursement Food & Agriculture Industrial & Environmental Bioethics & Biomedical Research Intellectual Property Regulatory Policies Tax & Fiscal Policies All Issues & Initiatives Press Releases Company...
Milestones 2003 Biotechnology Information, Advocacy and Business Support | About Us | BIO Events | BIO Members | Join BIO | Member Services | Links | Home CMS Payment System Prescription Coverage & Reimbursement Food & Agriculture Industrial & Environmental Bioethics & Biomedical Research Intellectual Property Regulatory Policies Tax & Fiscal Policies All Issues & Initiatives Press Releases Company...
Approved Biotechnology Drugs, 2002 Biotechnology Information, Advocacy and Business Support | About Us | BIO Events | BIO Members | Join BIO | Member Services | Links | Home CMS Payment System Prescription Coverage & Reimbursement Food & Agriculture Industrial & Environmental Bioethics & Biomedical Research Intellectual Property Regulatory Policies Tax & Fiscal Policies All Issues & Initiatives Press Releases Company...
Reference Listed Drug Labeling Approved in December 2002 Dec 2 VIREAD letter label tenofovir disoproxil fumarate tablets 21-356 SLR 001 AVANDIA letter -- rosiglitazone maleate tablets 21-071 SLR 008 Dec 3 PREVACID letter - lansoprazole delayed-release capsules 21-281 SLR 004 ---- PREVACID letter - lansoprazole oral suspension 20-406 SLR 048 Dec 4 ARIXTRA letter label fondaparinux Na injection 21-345 SLR 001 Dec 5 RYTHMOL letter -...
author: USERNAME
DOCUMENT INFORMATION PAGE DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 21- 142/ S- 007 Eleanor VOlux (clobetasol propionate) Foam, 0.05%...
author: DECAMP
DOCUMENT INFORMATION PAGE page 1
author: DECAMP
BIO Editors &Reporters 03LIVE page 62
author: Elinor
Document Information Page DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 NDA 21- 142/ S- 003 Connetics Corporation Attention: Linda Fenney, MD Senior Vice President 3400 West Bayshore Road Palo Alto, CA 94303 Dear Dr
author: CDER.USER
Document Information Page page 1
author: CDER.USER
DOCUMENT INFORMATION PAGE DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 21- 142/ S- 004 Connetics Corporation Attention: Sharon LOLUX ® (...
author: Kalyani Bhatt DDMAC REC 3.26.02
DOCUMENT INFORMATION PAGE page 1
author: Kalyani Bhatt DDMAC REC 3.26.02
http://www.fda.gov/cder/foi/label/2000/21142lbl.pdf OLUXaeFoam, 0.05% 1 (clobetasol propionate) 2 3 Rx Only 4 For Dermatologic Use Only 5 Not for Ophthalmic Use 6 7 DESCRIPTION 8 OLUX Foam contains clobetasol propionate, USP, a synthetic corticosteroid, for topical 9 dermatologic useOLUX Foam contains 0.5 mg clobetasol propionate, USP, in a 24 thermolabile foam, which consists of...
http://www.fda.gov/cder/foi/label/2000/21142lbl.pdf page 10
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