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Database X
X - 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...
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http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...
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../2002/21-196_Xyrem_
Food and Drug Administration • Center for Drug Evaluation and Research Title Search Xyrem (Sodium Oxybate) Oral Solution Company:--Orphan Medical Application No.:--21-196 Approval Date:-7/17/2002 Approval Letter(s) - Printed Labeling Part 1 - Part 2 - Medical Review(s)- Part 1 - Part 6 - Part 11 - Part 2 - Part 7 - Part 12 - Part 3 - Part 8 - Part 13 - Part 4 - Part...
author: USERNAME
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NMEs Approved in CY 2002
NMEs Approved in Calendar Year 2002 - NDA Number Generic Name Trade Name Dosage Form Applicant *Classification Approval Date 21-232 Nitisinone Orfadin Capsule Swedish Orphan -- 1PV 01-18-2002 21-286 Olmesartan Medoxomil Benicar Tablet Sankyo- 1S 04-25-2002 21-344 Fulvestrant Faslodex Injection AstraZeneca 1S 04-25-2002 21-272 Treprostinil Sodium Remodulin Injection United...
author: Susan Daugherty
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NDAs Approved under Subpart H
NDAs Approved under Subpart H NDA # Trade Name Generic -Name Clock Date Approval Date AP Time Approval Basis Indication - - - - - - - - 20199 Hivid Zalcitabine 31-Oct-91 19-Jun-92 7.6 S Combination therapy with zidovudine in advanced HIV infection - - - - - - - - 50698 Biaxin Clarithromycin- 2-Nov-92 23-Dec-93 13.7 S Treatment of disseminated mycobacterial infections due to...
author: Darlene Norris
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FDA Drug Approvals List July 2002
- Drug Approvals for July 2002 Definitions and Notes Original New Drug Applications Original New Drug Application # 021409 Approval Date: 26-JUL-02 Trade Name: SINGULAIR Chemical Type: 3 Therapeutic Potential: S Dosage Form: GRANULE Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC Active Ingredient(s): MONTELUKAST SODIUM OTC/RX Status: RX Indication of Use: PROPHYLAXIS/CHRONIC...
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Prescription and OTC Drug Product List 6/2002
-A- + GD SEARLE LLC EQ 500MG BASE/VIAL N18353 001 JUL CAHN -D- + SCS EQ 500MG BASE/VIAL N18353 001 JUL CAHN MIDAZOLAM HYDROCHLORIDE INJECTABLE; INJECTION MIDAZOLAM HCL -A- AP ABBOTT EQ 1MG BASE/ML N75857 001 JUL 22, 2002 JUL NEWA -A- AP EQ 5MG BASE/ML N75857 002 JUL 22, 2002 JUL NEWA MIDODRINE HYDROCHLORIDE TABLET; ORAL PROAMATINE -A- + SHIRE LABS 5MG N19815 002 SEP 06, 1996 JUL CRLD...
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http://www.orphan.com/Download/usprescibe.pdf
Table 2 Incidence (%) of Treatment- Emergent Adverse Events in Trial 1 Sodium Oxybate Dose Body System Placebo 3 g 6 g 9 g Preferred Term (n= 34) (n= 34) (n= 33) (n= 35) Body as a Whole Asthenia 1 (3%) 0 (0%) 2 (6%) 0 (0%) Flu Syndrome 0 (0%) 1 (3%) 0 (0%) 2 (6%) Headache 7 (21%) 3 (9%) 5 (15%) 11 (31%) Infection 1 (3%) 3 (9%) 5 (15%) 0 (0%) Infection Viral 1 (3%) 1 (3%) 3 (9%)...
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http://www.orphan.com/Download/usprescibe.pdf page 2
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http://www.orphan.com/Download/usprescibe.pdf page 1
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01-299 NewMedNeuroDis for PDF page 13
author: RL
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http://www.fda.gov/cder/foi/label/2002/21196lbl.pdf
doc 16 Table 2 Incidence (%) of Treatment- Emergent Adverse Events in Trial 1 Sodium Oxybate Dose Body System Placebo 3g 6g 9g Preferred Term (n= 34) (n= 34) (n= 33) (n= 35) Body as a Whole Asthenia 1 (3%) 0 (0%) 2 (6%) 0 (0%) Flu Syndrome 0 (0%) 1 (3%) 0 (0%) 2 (6%) Headache 7 (21%) 3 (9%) 5 (15%) 11 (31%) Infection 1 (3%) 3 (9%) 5 (15%) 0 (0%) Infection Viral 1 (3%) 1 (3%) 3 ...
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http://www.fda.gov/cder/foi/label/2002/21196lbl.pdf page 20
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http://www.fda.gov/cder/foi/label/2002/21196lbl.pdf page 10
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