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http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W/ CODEINE, CODEINE...
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21-038_Precedex.htm
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Precedex (Dexmedetomidine Hydrochloride) Company:- Abbott Laboratories Application No.:- 21-038 Approval Date:-12/17/1999 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Part 1 - Part 2 - Part 3 - Part 4 - Chemistry Review(s) - Pharmacology Review(s) - Part 1 ...
author: Paul Stauffer
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Report to the Nation: Drug Review
Priority new drug approvals: Alitretinoin Amprenavir (2 dosage forms) Aspirin/extended release-dipyridamole Bexarotene Busulfan Caffeine citrate Cytarabine liposome Dalfopristin/quinupristin Epirubicin hydrochloride Ganirelix acetate Ketotifen fumarate Levonorgestrel Nedocromil sodium Nitric oxide Orlistat Oseltamivir phosphate Pemirolast potassium Pioglitazone hydrochloride...
author: OLIVERN
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NMEs Approved in CY 1999
NMEs Approved in Calendar Year 1999 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date - - - - - - - 20-863 Cilostazol Pletal Tablet Otsuka Pharm 1S 01-15-1999 20-886 Alitretinoin Panretin Topical Gel Ligand Pharm 1-PV 02-02-1999 20-955 Sodium Ferric Gluconate Complex Ferrlicit Injectable R&D Labs 1P 02-18-1999 21-007 Amprenavir Agenerase...
author: Elaine Abraham
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APPROVED LABELING NDA 21-038/S-001
Precedex TM Dexmedetomidine Hydrochloride Injection DESCRIPTION Precedex™ (dexmedetomidine hydrochloride injection) is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution
Table 6: Potentially Clinically Relevant Treatment- Emergent Adverse Events to Dexmedetomidine Reported in 1% of Patients in the Continuous Infusion...
author: JFG
subject: PRECEDEX (DEXMEDETOMIDINE HCl INJECTION)
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APPROVED LABELING NDA 21-038/S-001 page 9
author: JFG
subject: PRECEDEX (DEXMEDETOMIDINE HCl INJECTION)
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APPROVED LABELING NDA 21-038/S-001 page 8
author: JFG
subject: PRECEDEX (DEXMEDETOMIDINE HCl INJECTION)
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APPROVED LABELING NDA 21-038/S-001 page 7
author: JFG
subject: PRECEDEX (DEXMEDETOMIDINE HCl INJECTION)
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APPROVED LABELING NDA 21-038/S-001 page 6
author: JFG
subject: PRECEDEX (DEXMEDETOMIDINE HCl INJECTION)
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APPROVED LABELING NDA 21-038/S-001 page 5
author: JFG
subject: PRECEDEX (DEXMEDETOMIDINE HCl INJECTION)
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APPROVED LABELING NDA 21-038/S-001 page 4
author: JFG
subject: PRECEDEX (DEXMEDETOMIDINE HCl INJECTION)
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APPROVED LABELING NDA 21-038/S-001 page 3
author: JFG
subject: PRECEDEX (DEXMEDETOMIDINE HCl INJECTION)
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APPROVED LABELING NDA 21-038/S-001 page 2
author: JFG
subject: PRECEDEX (DEXMEDETOMIDINE HCl INJECTION)
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APPROVED LABELING NDA 21-038/S-001 page 1
author: JFG
subject: PRECEDEX (DEXMEDETOMIDINE HCl INJECTION)
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CDER 1999 Report to the Nation
1999 new molecular entities: Alitretinoin (Panretin) Aminolevulinic acid hydrochloride (Levulan Kerastick) Amprenavir (Agenerase) Bexarotene (Targretin) Cilostazol (Pletal) Dalfopristin/ quinupristin (Synercid) Dexmedetomidine hydrochloride (Precedex) Dofetilide (Tikosyn) Doxercalciferol (Hectorol) Entacapone (Comtan) Epirubicin hydrochloride (Ellence) Exemestane ...
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
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CDER 1999 Report to the Nation page 13
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
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CDER 1999 Report to the Nation page 11
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
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http://www.fda.gov/cder/foi/label/1999/21038lbl.pdf
Dexmedetomidine HCl December 23, 1999 Draft Labeling 1 PRECEDEX TM DEXMEDETOMIDINE HYDROCHLORIDE Injection DESCRIPTION PRECEDEX TM (dexmedetomidine hydrochloride injection) is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution
Table 6: Potentially Clinically Relevant Treatment- Emergent Adverse Events to Dexmedetomidine...
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http://www.fda.gov/cder/foi/label/1999/21038lbl.pdf page 13
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http://www.fda.gov/cder/foi/label/1999/21038lbl.pdf page 12
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http://www.fda.gov/cder/foi/label/1999/21038lbl.pdf page 11
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http://www.fda.gov/cder/foi/label/1999/21038lbl.pdf page 10
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http://www.fda.gov/cder/foi/label/1999/21038lbl.pdf page 9
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http://www.fda.gov/cder/foi/label/1999/21038lbl.pdf page 8
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http://www.fda.gov/cder/foi/label/1999/21038lbl.pdf page 7
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