|
|
|
|
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,...
|
|
|
FDA Drug Approvals List June 2001
PERRIGO COMPANY Active Ingredient(s): MONOXIDIL OTC/RX Status: RX Original Abbreviated Application # 075750 Approval Date: 8-JUN-01 Trade Name: DOXAZOSIN MESYLATE Dosage Form: TABLET Applicant: SIDMAK LABORATORIES, INC Active Ingredient(s): DOXAZOSIN MESYLATE OTC/RX Status: RX Original Abbreviated Application # 075502 Approval Date: 05-JUN-01 Trade Name: CLOTRIMAZOLE AND...
|
|
|
Prescription and OTC Drug Product List 6/2002
-D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
|
|
|
http://www.fda.gov/cder/da/ddpa94.wpd
20-374 INPERSOL-LC ABBOTT CALCIUM CHLORIDE 23-DEC-93 W/DEXTROSE 1.5% ABBOTT PARK, IL 18.4MG/100ML IN PLASTIC CONTAINER 60064 DEXTROSE (SOLUTION) 1.5GM/100ML MAGNESIUM CHLORIDE 5.08MG/100ML SODIUM CHLORIDE 538MG/100ML SODIUM LACTATE 448MG/100ML (PERITONEAL DIALYSATE) 20-374 INPERSOL-LC ABBOTT CALCIUM CHLORIDE 23-DEC-93 W/DEXTROSE 2.5% ABBOTT PARK, IL 18.4MG/100ML IN PLASTIC CONTAINER...
|
|
|
Drug Approvals - Z
Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted ZADITOR (ketotifen fumarate ophthalmic solution) 0.025%, Rx Ciba Vision NDA 21-066 7/2/99 7/6/99 7/6/99 3/31/02 ZADITOR (ketotifen fumarate ophthalmic solution) 0.025%, Rx Ciba Vision NDA 21-066/S4 07/20/01 05/08/03 - ZADITOR Indication: for the prevention of itching of the eye due to allergic...
|
|
|
What's new at CDER by Date
- U.S
New and Generic Drug Approvals Curosurf (poractant alfa) Intratracheal Suspension, Dey Glyburide & Metformin Hydrochloride Tablets, Ivax Pharmaceuticals HYDREA (hydroxyurea) Capsules, Bristol-Myers Squibb Company Methergine (Methylergonovine Maleate) Tablets & Injection, Novartis M.V.I
Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Genpharm Benazepril...
author: Paul Stauffer
|
|
|
EMRindex2003.qxd page 15
author: mcintosht
|
|
|
EMRindex2003.qxd page 12
author: mcintosht
|
|
|
Pharmaceutical Research and Manufacturers of America
- Organon Complete a new search Drug Name (Proprietary name/Generic name) Indications Addressed Click on indication to see all drugs for that indication Company Click a company to see all drugs for that company Development Status Notes CTR 99 none / CTR 99 Contraception Organon West Orange, NJ application submitted - gepirone none / gepirone Depression Organon West Orange, NJ...
|
|
|
Reference Listed Drug Labeling Approved in March 2000
19-909 S-014 Glaxo Wellcome 15 CLOZARIL Clozapine/tab 19-758 S-041 Novartis Pharms 17 VIOXX Rofecoxib/tab 21-042 S-003 Merck Res 17 VIOXX Rofecoxib/oral sol 21-052 S-003 Merck Res 17 BRETHINE Terbutaline sulfate/inj 18-571 S-015 Novartis Pharms 21 PANHEPARIN Heparin Na/inj 5-264 S-073 Abbott Labs 21 TRIPHASIL Levonorgestrel/ethinyl estradiol/tab 19-192 S-035 Wyeth Ayerst Labs 23...
author: USERNAME
|
|
|
Reference Listed Drug Labeling Approved in June 2001
Jun 1 CEFAZOLIN AND DEXTROSE letter label cefazolin for injection/dextrose injection 50-779 S-001 Jun 5 LIMBITROL DS letter label chlordiazepoxide/amitriptyline HCl tablets 16-949 S-033 ZEMURON letter label rocuronium bromide injection 20-214 S-013 Jun 6 MENTAX letter label butenafine HCl cream 20-524 S-005 Jun 8 INTEGRILIN letter label eptifibatide injection 20-718 S-013...
author: USERNAME
|
|
|
http://www.fda.gov/cder/foi/label/2001/20214s13lbl.pdf
epatic Disease Sin e ZEMURON ® ( o u onium b omide) Inje tion is p ima ily ex eted by the live , it should be used with aution in patients with lini ally signifi ant hepati ZEMURON ® 0
Infusion solutions of ZEMURON ® an be p epa ed by mixing ZEMURON ® with an app op iate infusion solution su h as 5% glu ose in wate tated Ringe s ( see...
|
|
|
01-105 New Med Child pf.cc
Johnson pain application submitted tramadol Pharmaceutical 7 yearsTH 16 years Research Institute (908) 704- 4000 Raritan, NJ Zemuronª Organon neuromuscular blocking agent in application submitted rocuronium West Orange, NJ general anesthesia to facilitate pediatric patients bromide tracheal intubation and provide (800) 241- 8812 skeletal muscle relaxation during...
author: RL
|
|
|
01-105 New Med Child pf.cc page 13
author: RL
|
|
|
D:\My Documents\NDA Supplements\N 20-214 s-013 AP.doc page 1
author: Kimberly Compton
|
|
|
1999 Warning Letters and Untitled Letters to Pharmaceutical Companies
DSI 4/9/99 5/21/99 Combivir Tablets Glaxo Wellcome DDMAC 4/23/99 5/18/99 Detrol (tolterodine tartrate) tablets Pharmacia & Upjohn DDMAC 4/13/99 5/18/99 Ditropan XL (oxybutynin chloride) tablets Alza Corporation DDMAC 4/2/99 4/14/99 Livostin (levocabastine HCl) ophthalmic suspension Ciba Vision DDMAC 4/6/99 4/14/99 Lovenox (enoxaparin sodium) injection Rhone-Poulenc Rorer DDMAC 4/8/99...
|
|
|
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
PROPARACAINE HCL 2712 03-Aug-76 PHARMACIA AND UPJOHN INC "HEPARIN, SODIUM U.S.P." 2716 10-Aug-76 SMITHKLINE CORP "CIMETIDINE AND CIMETIDINE HCL MANUFACTURED IN CORK, IRELAND." 2719 09-Aug-76 PLANTEX LTD CHEM AND PHARM WORKS AMITRIPTYLINE HCL 2726 05-Aug-76 SCHERING AG NORETHINDRONE 2736 19-Jul-76 ROUSSEL-UCLAF "DEXAMETHASONE ACETATE ANHYDROUS USP MANUFACTURED IN VERTOLAYE, FRANCE."...
|
