http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
BREVIBLOC PREMIXED INJECTION page 6
author: Baxter Healthcare Corporation
BREVIBLOC PREMIXED INJECTION Esmolol Hydrochloride concentration = 10 milligrams/ mL (10,000 micrograms/ mL) Single Patient Use Only No Preservatives Added BREVIBLOC DOUBLE STRENGTH PREMIXED INJECTION (Esmolol Hydrochloride) 2,000 mg/ 100 mL (20 mg/ mL) Ready- to- use Bags 100 mL Bags Iso- Osmotic Solution of Esmolol Hydrochloride in Sodium Chloride For Intravenous Use Can be used for direct...
author: Baxter Healthcare Corporation
7000 rev0703 page 8
7000 rev0703 page 7
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AP + WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC >A> @ 5,000 UNITS/VIAL N17055 001 JUN DISC >D> AP + 10,000 UNITS/VIAL N17055 002 JUN DISC >A> @ 10,000 UNITS/VIAL N17055 002 JUN DISC GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE >D> AB WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >A> AB + EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >D> WYTENSIN >D> AB WYETH...
author: AUTHOR
TAZTIA! page 2
author: Jamie Dorgan
rld_labeling_approved_may_1999 Firm Date ISUPREL Isoproterenol Hydrochloride Injection 10-515 S-022 Abbott 4-May-1999 PATINOL /PLATINOL-AQ Cisplatin For Injection/Cisplatin Injection 18-057 S-068 Bristol Myers Squibb 5-May-1999 MAXAQUIN Lomefolxacin Hydrochloride 20-013 S-013 Searle 6-May-1999 URACIL MUSTARD Uracil Mustard capsules 12-892 S-001 Roberts Labs 6-May-1999 ESTROSTEP Norethindrone...
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...
TIMPILO Product Monograph PRODUCT MONOGRAPH TIMPILO ® (timolol maleate and pilocarpine hydrochloride ophthalmic solution) Sterile Olphthalmic Solution THERAPEUTIC CLASSIFICATION ELEVATED INTRAOCULAR PRESSURE THERAPY DESCRIPTION TIMPILO ® (timolol maleate and pilocarpine hydrochloride) is a fixed combination of timolol maleate 0.5% and pilocarpine hydrochloride 2% (TIMPILO ® 2) or 4% (TIMPILO &...
author: Merck Frosst Canada & Co.
subject: 644-a,5,00
TIMPILO Product Monograph page 5
author: Merck Frosst Canada & Co.
subject: 644-a,5,00
COSOPT - Product Monograph If necessary during surgery, the effects of beta- adrenergic blocking agents may be reversed by sufficient doses of such agonists as isoproterenol, dopamine, dobutamine or levarterenolisoproterenol hydrochloride should be administered cautiouslyisoproterenol hydrochloride
author: Merck Frosst Canada Ltd.
subject: 778-b,11,02
FDA Drug Approvals List February 2000 - Drug Approvals for February 2000 Definitions and Notes Original New Drug Applications Original Application #: 021015 Approval Date: 28-FEB-00 Trade Name: ANDROGEL Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: UNIMED PHARMACEUTICALS INC Active Ingredient(s): TESTOSTERONE OTC/RX Status: RX Indication(s): For replacement therapy in males for conditions...
SSCI Inc.: X-ray Powder Diffraction, Raman and Infrared Spectroscopy, Differential Scanning Calorimetry, and Thermogravimetric Phone: 800 375-2179 / 765 463-0112 Fax: 765 497-2649 / 765 463-4722 E-mail: info@ssci-inc.com SSCI Inc., 3065 Kent Avenue, West Lafayette, IN 47906 - 1076 USA Acetaminophen Acetazolamide Acetohexamide Acetylcysteine Acyclovir Adenine L-Alanine Albuterol Albuterol Sulfate Allopurinol Alprazolam Amantadine HCl Amiloride HCl Aminobenzoic Acid Aminoglutethimide Aminosalicylic Acid...
author: SSCI Webmaster
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices Ioxaglate Sodium Iron Dextran Injection Iron Sorbitex Isobucaine HCI and Epinephrine Isoniazid Isoproterenol HCI Injection Isosuifan Sulfate Isoxsupine HCI Injection Kanamycin Sulfate Injection Ketamine HCI Labetalol HCI Leucovorin Calcium Injection Leuprolide Acetate Levallorphan Tartrate Injection Levarterenol Levorphanol Tartrate Injection Levothyroxine Sodium for Injection...
author: FDA / CBER
subject: December 1987 Guideline
http://www.medvet.com.au/downloads/drg_scr/sitescreen_product_insert.pdf M e t h a d o n e: Methadone is a synthetic analgesic drug that is originally used in the treatment of narcotic addicts. Among the psychological effects induced by using methadone are analgesia, sedation and respiratory depression. Overdose of methadone may cause coma or even death. It is administered ...
http://www.medvet.com.au/downloads/drg_scr/sitescreen_product_insert.pdf page 2 PERFORMANCE CHARACTERISTICS A. Accuracy For each individual drug screen assay, approximately 60 urine samples of specific drugs were obtained form clinical laboratories. The concentration of drug present in the samples was determined by either GC/ MS or commercial kits. Each sample was then ...
Prescription and OTC Drug Product List 12/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 12: December 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE ALBUTEROL SULFATE - ADD - SOLUTION; ORAL SOLUTION; INHALATION - ADD - ZIAGEN ALBUTEROL SULFATE - ADD - + GLAXO WELLCOME EQ 20MG BASE/ML N20978 001 - ADD - @ COPLEY PHARM...
Prescription and OTC Drug Product List 2/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 2: February 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CICLOPIROX TABLET; ORAL CREAM; TOPICAL LORTAB LOPROX - DLT - UCB 325MG;5MG N40099 001 - ADD - + AVENTIS PHARMS 0.77% N18748 001 - DLT - JUN 25, 1997 - ADD -...
SUPAC Chair, CMC CC Appendix A Narrow Therapeutic Range Drugs Aminophylline Tablets, ER Tablets Carbamazepine Tablets, Oral Suspension Clindamycin Hydrochloride Capsules Clonidine Hydrochloride Tablets Clonidine Transdermal Patches Dyphylline Tablets Disopyramide Phosphate Capsules, ER Capsules Ethinyl Estradiol/Progestin Oral Contraceptive Tablets Guanethidine Sulfate Tablets...
FDA Drug Approvals List- May 1999 Efficacy Supplemental New Drug Applications Application #: 020584 Efficacy Supplement#: 003 Type: SE2 to Original New Drug Application Approval Date: 27-MAY-99 Trade Name: LODINE XL Dosage Form: TABLET, EXTENDED RELEASE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): ETODOLAC OTC/RX Status: RX Efficacy Claim: For the management of the signs and symptoms of...
http://www.fda.gov/cder/rdmt/escy99ap.htm - - - - - - - - - - TERBINAFINE HYDROCHLORIDE NOVARTIS 20-980 03/30/98 03/09/99 N 0 N 11.3 Rx to OTC switch for the treatment of tinea pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ringworm)ISOPROTERENOL HYDROCHLORIDE ABBOTT LABS 10-515 01/05/98 05/04/99 SE1 22 N 15.9 -Pediatric Use- subsection added to labeling
author: Darlene
aNp.SYMMETREL.10/97 page 9
author: Linda Wolff
http://www.fda.gov/cder/ogd/rld/20255s6.PDF page 2
http://www.fda.gov/cder/ogd/rld/11178s37.pdf page 3
