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 ...
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 8/2001 ACTHAR GEL -D- BC + AVENTIS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -D- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN -A- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -A- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN DELAVIRDINE MESYLATE TABLET; ORAL RESCRIPTOR -D- + AGOURON 100MG N20705 001 APR 04, 1997 AUG CRLD -A- 100MG N20705 001 APR 04, 1997 AUG...
PDPL PRESCRIPTION DRUG PRODUCT LIST- 16TH EDITION RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 8 / JAN'96 - AUG'96 ACETAMINOPHEN; BUTALBITAL ALPRAZOLAM TABLET; ORAL TABLET; ORAL BUTALBITAL AND ACETAMINOPHEN ALPRAZOLAM - DLT - AB HALSEY 325MG;50MG N89568 001 - ADD - AB NOVOPHARM 2MG N74085 004 - DLT - OCT 05, 1988 - ADD - FEB 26, 1996 - ADD - @ 325MG;50MG N89568 001 - ADD - OCT 05,...
Esoterix, Inc. -- Test Menu parapertussis) 606099 Bordetella Parapertussis Smear 607122 Bordetella Pertussis Antibody [MAT] *** 607124 Bordetella Pertussis Antibody Profile, IgG, IgA, IgM *** 609350 Bordetella Pertussis Culture & DFA 606010 Bordetella Pertussis Smear [DFA] 133050 Boron (B), Urine - BR 27.29 - see 500395 - CA 27.29 1398210 Breast Milk Drug Panel 10: Amphetamines, Barbiturates, Benzodiazepines,...
author: Esoterix, Inc.
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt IN ANDHRA PRADESH, INDIA." 10830 24-Mar-94 YUNG ZIP CHEMICAL INDUSTRY CO LTD AIC "ACYCLOVIR MANUFACTURED IN TACHIA, TAIWAN, REPUBLIC OF CHINA." 10836 30-Mar-94 KYOWA HAKKO KOGYO CO LTD "SODIUM HYALURONATE MANUFACTURED IN UBE-SHI, JAPAN." 10837 28-Mar-94 ERREGIERRE SPA "FLUOXETINE HYDROCHLORIDE MANUFACTURED IN BERGAMO, ITALY." 10838 29-Mar-94 SANDOZ GMBH "7-AMINO-3-PROPENYL...
EMRindex2003.qxd See Glasgow Coma Scale Genital mutilation, female, 5: 62 Gentamicin for IDU- related infectious endocarditis, 15: 202- 203, 203t for open fractures, 21: 281 for pyelonephritis, 7: 93t, 10: 141t Geriatric patients, 26: 351 Giardia lamblia, 4: 39, 40t Glasgow Coma Scale (GCS), 11: 148, 149t Glasgow or Imrie criteria, 19: 250, 250t Glasgow Outcome Coma Scale, 11: 158, 158t Glenn shunt,...
author: mcintosht
Geriatric Emergencies 0,1,2 errors X 2 n Say months in reverse 0,1,2 error X2 Repeat phrase =0,1,2,3,4,5 errors X 2 Scoring Brief Mental Status Exam n 0 = best 28 total 0-8 are normal 9-19 – mild impairment 20-28 – severe impairment Initial Stabilization n Monitored bed n ABC’s Check for hypoxia (Consider CO poisoning, give O2) IV NS or RL, stat bloodwork Glucose, thiamine 100mg iv, narcan...
author: Caroline Kowal
FDA Drug Approvals List August 2001 Active Ingredient(s): PHENTERMINE HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Application #: 076045 Tentative Approval Date: 29-AUG-01 Trade Name: LORAZEPAM Dosage Form: TABLET Applicant: RANBAXY LABORATORIES LIMITED Active Ingredient(s): LORAZEPAM OTC/RX Status: RX Original Abbreviated Application #: 076035 Tentative Approval Date: 29-AUG-01 Trade Name: HALOPERIDOL ...
FDA Drug Approvals List March 2001 Original Application #: 021082 Approval Date: 01-MAR-01 Trade Name: TAVIST ALLERGY/SINUS/HEADACHE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: NOVARTIS CONSUMER HEALTH INC Active Ingredient(s): ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE OTC/RX Status: OTC Indication(s): For temporary relief of symptoms associated with hay fever,...
FDA Drug Approvals List April 2002 JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): HALOPERIDOL OTC/RX Status: RX Application #: 011340 Labeling Supplement #: 016 To Original New Drug Application Approval Date: 17-APR-02 Trade Name: CERUMENEX Dosage Form: SOLUTION Applicant: PURDUE FREDERICK CO Active Ingredient(s): TRIETHANOLAMINE POLYPEPTIDE OLEATE CONDENSATE OTC/RX Status: OTC Application #:...
Prescription and OTC Drug Product List 12/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL SYNALGOS-DC-A -A- @ WOMEN FIRST HLTHCARE 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN -D- @ WYETH AYERST 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL ANEXSIA 5/325 -D- AA MALLINCKRODT 325MG;5MG N40409...
Prescription and OTC Drug Product List 8/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -A- AA ABLE 300MG;30MG N40452 001 AUG 01, 2002 AUG NEWA -A- AA 300MG;60MG N40459 001 AUG 01, 2002 AUG NEWA ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE TABLET; ORAL ACETAMINOPHEN AND PENTAZOCINE HCL -A- AB AMIDE PHARM 650MG;EQ 25MG BASE N76202 001 AUG...
Prescription and OTC Drug Product List 5/2002 2 -D- + ROBINS AH 325MG;15MG N84444 001 MAY DISC -A- @ 325MG;15MG N84444 001 MAY DISC SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -D- AA ALPHARMA 120MG/5ML;12MG/5ML N85861 001 MAY CRLD -A- AA + 120MG/5ML;12MG/5ML N85861 001 MAY CRLD TYLENOL W/ CODEINE -D- AA + JOHNSON RW 120MG/5ML;12MG/5ML N85057 001 MAY DISC -A- @ 120MG/5ML;12MG/5ML N85057 001 MAY DISC TABLET; ORAL...
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...
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 Conc.( equine) 3.00 mL Dipyridamole 0.14 mg Dobutamine HCI 0.90 mg 5.00 1.10 2.17 3.57 1.80 1.80 1.80 1.80 45.45 5.00 1.25 5.56 11.60 + 0.50 + 35.70 + 71.43 16.70 + 17.20 + 0.70 + 0.70 + 111.00 + 200.00 + 1.00 357.00 0.003 + 0.50 + 166.67 1.00 4.00 0.50 + 1.00 8.77 3.40 + 16.67 1.67 37.70 5.56 40 Dopamine HCI Dopamine HCl in Dextrose Doxapram HCI Injection Doxorubicin HCI for...
author: FDA / CBER
subject: December 1987 Guideline
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 page 9
author: FDA / CBER
subject: December 1987 Guideline
Diagnostics TEST GTT GLUCOSE TOLERANCE TEST -- GTTE GLUCOSE TOL'NCE TEST EXT GTTI GLUCOSE TOLERANCE+INSULIN GUT3 GUTHRIE (PKU + TSH + IRT) GUTF GUT FERMENTATION PROFILE GUTH GUTHRIE TEST (PKU + TSH) GUTP GUT HORMONE PROFILE ----- H2N HER-2-NEU --------------- HABC HLA A B AND C ANTIGENS -- HAIM HEPATITIS A IMMUNITY ---- HALO HALOPERIDOL (SERUM) ----- HALT ALANINE TRANSFERASE (HMR) HAMS...
Prescription and OTC Drug Product List 1/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 1: Jan 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE ALPROSTADIL TABLET; ORAL INJECTABLE; INJECTION PRECOSE PROSTIN VR PEDIATRIC - DLT - @ BAYER 25MG N20482 004 - DLT - + PHARMACIA AND UPJOHN 0.5MG/ML N18484 001 - DLT - MAY 29, 1997 - ADD -...
Prescription and OTC Drug Product List 3/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 3: January-March 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ATORVASTATIN CALCIUM CAPSULE; ORAL TABLET; ORAL - ADD - BUTALBITAL; ACETAMINOPHEN; AND CAFFEINE WITH CODEINE LIPITOR - ADD - PHOSPHATE ...
Prescription Drug Product List 1/96 PRESCRIPTION DRUG PRODUCT LIST 16TH EDITION RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'96 ACETAMINOPHEN; CODEINE PHOSPHATE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE TABLET; ORAL - ADD - ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION; INTRAPERITONEAL - ADD - AA MIKART 300MG;60MG N89244 001 - ADD - DELFLEX W/ DEXTROSE 4.25% IN...
FDA Drug Approvals List May 2000 Dosage Form: INJECTABLE Applicant: ASTRAZENECA UK LTD Active Ingredient(s): MEROPENEM OTC/RX Status: RX Application #: 020073 Labeling Supplement#: 010 To Original New Drug Application Approval Date: 22-MAY-00 Trade Name: ROMAZICON Dosage Form: INJECTABLE Applicant: HLR TECHNOLOGY Active Ingredient(s): FLUMAZENIL OTC/RX Status: RX Application #: 020760 Labeling Supplement#: 006 To...
DDPA November 1995 20-469 BECLOMETHASONE SCHERING BECLOMETHASONE DIPROPIONATE 09-NOV-95 DIPROPIONATE KENILWORTH, NJ MONOHYDRATE MONOHYDRATE 07033 EQ 0.084MG DIPROP/INH (SPRAY, METERED) (STEROID) 20-539 LAMISIL SANDOZ TERBINAFINE HYDROCHLORIDE 21-NOV-95 (TABLET) EAST HANOVER, NJ EQ 250MG BASE 07936 (ANTIFUNGAL) 20-291 COMBIVENT BOEHRINGER INGELHEIM ALBUTEROL SULFATE 22-NOV-95 (AEROSOL, METERED)...
DDPA August 1996 74-635 NAPROXEN SODIUM NOVOPHARM NAPROXEN SODIUM 20-AUG-96 (TABLET) SCARBOROUGH, ONTARIO 220MG CANADA (NONSTEROIDAL ANTI-INFLAMMATORY) 74-570 ACYCLOVIR ROXANE LABS ACYCLOVIR 30-AUG-96 (CAPSULE) COLUMBUS, OH 200MG 43216 (ANTIVIRAL) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 08-678 ISONIAZID EON MANUFACTURE LABS ISONIAZID 01-AUG-96 (TABLET) LAURELTON, NY 100MG 11413 300MG (LABELING...
August Drug Approvals Original Application #: 020508 Approval Date: 29-AUG-96 Trade Name: LAC-HYDRIN Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: BRISTOL MYERS CO Active Ingredient(s): AMMONIUM LACTATE OTC/RX Status: RX Indication(s): ICHTHYOSIS VULGARIS AND XEROSIS Original Application #: 020532 Approval Date: 26-AUG-96 Trade Name: IVY BLOCK Chemical Type: 1 Therapeutic...
