http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
DDPA December 1995 Drug and Device Approvals-December 1995 December 1995 - FDA Drug and Device Product Approvals ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-628 INVIRASE ROCHE SAQUINAVIR MESYLATE 06-DEC-95 (CAPSULE) NUTLEY, NJ EQ 200MG BASE (1 P, AA*, E**, H***) 07110 (ANTIVIRAL) [TREATMENT OF ADVANCED HIV INFECTION IN SELECTED PATIENTS IN COMBINATION WITH NUCLEOSIDE ANALOGUES] 19-835...
http://www.iomed.com/pdf/Numby-900-Application-Guide.pdf Specifications Dose 40 mA- minutes Current Range 0 to 4.0 mA (2.0 mA, 3.0 mA and 4.0 mA constant current) Maximum Voltage 60V.IONTOCAINE ® * , the Numby 900 delivers anesthesia without needles.
http://www.iomed.com/pdf/Numby-900-Application-Guide.pdf page 2
AW1907202Rv0BCmp80_DFU ° Note: Clip hair, if necessary, to improve contact with skin.
author: Stephen Krawic
AW1907202Rv0BCmp80_DFU page 1
author: Stephen Krawic
Microsoft Word - Document2 IONTOCAINE ® Package Insert Clinical Pharmacology Mechanism of Action: Iontophoresis is a drug delivery method that uses a small external electric current to deliver water- soluble, charged drugs into the skin.Iontocaine causes a transient, local blanching followed by a transient, local redness, or erythema.
author: pld
Microsoft Word - Document2 page 6
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Microsoft Word - Document2 page 1
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AW1907217Rv0AOptimADFU PREPARING PATIENT 1.Iontocaine &...
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AW1907195Rv0AGelSpgDFU PREPARING PATIENT 1.Iontocaine ® (Lidocaine ...
author: Stephen Krawic
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author: Stephen Krawic
http://www.fda.gov/cdrh/pdf3/k031115.pdf page 5
FACT SHEET SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES INCLUDING OXYGEN, CORTICOSTEROIDS, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED
author: K. Notarianni
MAX0173 Full PI-4 pager SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES INCLUDING OXYGEN, CORTICOSTEROIDS, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED
author: Freelance
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 11274 27-Dec-94 FUJI CHEMICAL INDUSTRIES LTD "DINOPROSTONE (PROSTAGLANDIN E2) MANUFACTURED IN TOYAMA, JAPAN." 11276 29-Dec-94 TAKASAGO INTERNATIONAL CORP "A-87172.0 MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN." 11280 04-Jan-95 PLIVA "MESALAZINE N MANUFACTURED IN SAVSKI MAROF, CROATIA" 11282 05-Jan-95 KANEKA CORP "KPM-1648 MANUFACTURED IN HYOGO, JAPAN" 11287 29-Dec-94 DOW CHEMICAL CO ...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls ACETOHEXAMIDE MFG.PAULLO(MILANO)FACILITY ON VIA CURIEL(WAS LIDOCAINE) DIOSYNTH BV ESTRADIOL MICRONIZED PHARMACIA AND UPJOHN COMPANY NICORETTE (R): PRODUCTION OF CHEWING GUM AT THE ESBJERG, DENMARK PLANT PHARMACIA AND UPJOHN COMPANY NICORETTE (R) CHEWING GUM DIOSYNTH BV HYDROXYPROGESTERONE CAPROATE LONZA INC DEXTROMETHOPHAN HYDROBROMIDE AS MFG
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AT ALLERGAN 1% N61187 001 JUN DISC >A> @ 1% N61187 001 JUN DISC >D> SOLUTION/DROPS; OPHTHALMIC >D> CHLOROPTIC >D> + ALLERGAN 0.5% N50091 001 JUN DISC >A> @ 0.5% N50091 001 JUN DISC >D> CHLOROQUINE HYDROCHLORIDE >D> INJECTABLE; INJECTION >D> ARALEN HCL >D> + SANOFI SYNTHELABO EQ 40MG BASE/ML N06002 002 JUN DISC >A> @ EQ 40MG BASE/ML N06002 002 JUN DISC CHLORPROMAZINE ...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 5/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
Prescription and OTC Drug Product List 9/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- ENDO PHARMS 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -D- 400MG;7.5MG N40288 002 NOV 27, 1998 SEP CTEC -D- 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -A- + 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;7.5MG...
Prescription and OTC Drug Product List 7/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS 325MG;7.5MG...
Prescription and OTC Drug Product List 6/2002 45 -D- + NOVARTIS 1MG/ML N05929 001 JUN CAHN -A- XCEL PHARMS 1MG/ML N05929 001 JUN CAHN DILTIAZEM HYDROCHLORIDE INJECTABLE; INJECTION CARDIZEM -D- AP + AVENTIS PHARMS 5MG/ML N20027 001 OCT 24, 1991 JUN CAHN -D- + 25MG/VIAL N20027 003 AUG 18, 1995 JUN CAHN -A- AP + BIOVAIL 5MG/ML N20027 001 OCT 24, 1991 JUN CAHN -A- + 25MG/VIAL N20027 003 AUG 18, 1995 JUN CAHN DILTIAZEM MALATE;...
V:\DAIDP\PEAT\Approval Letter\N50679SE2.doc SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES INCLUDING OXYGEN, CORTICOSTEROIDS, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED
author: Raquel Peat
