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, ...
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 +...
TOXICOLOGY PROFILES/COMBINATIONS - Volatiles Acetone Ethanol Isopropanol Methanol - Barbiturates Amobarbital (Amytal®) Butabarbital (Butisol Sodium®) Butalbital (Sandoptal®, Fiorinal®) Pentobarbital (Nembutal®) Phenobarbital (Luminal®) Secobarbital (Seconal TM ) - *Benzodiazepines Chlordiazepoxide (Librium®) Diazepam (Valium®) - Others Acetaminophen (Tylenol®, Datril®)...
Specificity Table TOX.xls Tested (ng/ ml) Persantine Dipyridamole Coronary vasodilator 100,000 Pethidine Meperidine Narcotic analgesic 100,000 Pethidine metabolite Meperidine metab.( Normeperidine) Meperidine metabolite 100,000 Peyote Mescaline Hallucinogen 100,000 Phanurane Canrenoic acid Diuretic 100,000 Phenergan Promethazine Antihistaminic 100,000 Phenoverm Phenothiazine Anthelmintic 100,000 Phenylacetone...
author: Biosite Incorporated
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.
CDER Guidance Documents (Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [ PDF ] M4 Common Technical Document--Quality: Questions and Answers/Location Issues [ HTML ] or [ PDF ] or [ ] (Issued 9/12/2002, Posted 12/30/2002) Quality Q1E Evaluation of...
Drug Approvals - B ANDA 75-618 3/23/01 3/30/01 - - Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules USP, 50 mg/325 mg/40 mg/30 mg, Rx Jerome Stevens Pharmaceuticals ANDA 74-951 8/31/98 9/2/98 - 9/26/02 Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules USP- Endo Pharmaceuticals, IncButalbital, Aspirin...
Maximum Recommended Therapeutic Dose (MRTD) Database Maximum Recommended Therapeutic Dose (MRTD) Database (1,235 pharmaceuticals) A -- B- - C -- D -- E -- F-G -- H-K -- L -- M -- N -- O -- P -- Q-R -- S -- T -- U-Z MRTD--- (mg/kg--- bw/day) -- Generic Chemical Name Chemical Structure (SMILES Code) 3.00000-- Acemetacin C1=C(OC)C=C3C(=C1)N(C(=O)C2=CC=C(Cl)C=C2)C(C)=C3CC(=O)OCC(O)=O 0.20000-- Acenocoumarol C1=CC=C3C(=C1)OC(=O)C(C(CC(C)=O...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt TEMAZEPAM 4381 14-Sep-81 DINAMITE DIPHARMA SPA METOCLOPRAMIDE HYDROCHLORIDE BP'80 4395 25-Nov-81 DANISCO INGREDIENTS BUTALBITAL 4397 22-Dec-81 HOVIONE SOCIEDADE QUIMICA LDA BETAMETHASONE 17-VALERATE 4416 23-Jan-82 LABORATORIO CHIMICO INTERNATIONAL SPA CARISOPRODOL 4420 03-Feb-82 SOCIETA ITALIANA CORTICOSTEROIDI SPA DESONIDE 4423 03-Feb-82 AVENTIS PHARMA SA FLUOROMETHOLONE 4431...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls DIAZEPAM AVENTIS PHARMA SA CHLORPROMAZINE HYDROCHLORIDE PHARMACIA AND UPJOHN INC CYTARABINE AS MANUFACTURED IN KALAMAZOO MI PHARMACIA AND UPJOHN INC MEDRYSONE PHARMACIA AND UPJOHN INC FLUOROMETHOLONE MICRONIZED AVENTIS PHARMA SA CROMOLYN SODIUM AND CROMOLYN SODIUM/LACTOSE BLEND ADAMHA NIMH DELTA-9-TRANS-TETRAHYDROCANNABINOL-DELTA-9-TRANS-TETRAHYDROCANNABINOL SSL INTERNATIONAL...
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-...
author: AUTHOR
DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY Food and Drug Administration • Center for Drug Evaluation and Research Approved Drug Products Search DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION - ACETAMINOPHEN; ASPIRIN; BUTALBITAL CAPSULE OR TABLET; ORAL 160-165MG; 160-165MG; 50MG ACETAMINOPHEN; ASPIRIN; BUTALBITAL CAPSULE OR TABLET;...
author: USERNAME
ANDA Approvals November 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - November 2001 - - ANDA Number Drug Name Applicant Approval Date 1 75-916 RIMANTADINE HYDROCHLORIDE TABLETS 100 MG COREPHARMA LLC 11/2/01 2 75-682 IBUPROFEN TABLETS, USP 400 MG, 600 MG, AND 800 MG BASF CORPORATION 11/14/01 3 75-347 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG,...
author: USERNAME
Aspirin, Butalbital, Caffeine and Codeine Phosphate Capsules USP Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Aspirin, Butalbital, Caffeine and Codeine Phosphate Capsules USP Company:- Endo Pharmaceuticals Inc
author: USERNAME
Prescription and Over-the-Counter Drug Product List: 3/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG...
author: AUTHOR
FDA Drug Approvals List November 2001 - Drug Approvals for November 2001 Definitions and Notes Original New Drug Applications Original Application #: 021277 Approval Date: 30-NOV-01 Trade Name: AVELOX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: BAYER CORP PHARMACEUTICAL DIV Active Ingredient(s): MOXIFLOXACIN HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of adults ...
FDA Drug Approvals List October 2001 Active Ingredient(s): OXAPROZIN OTC/RX Status: RX Original Abbreviated Application # 075839 Approval Date: 1-OCT-01 Trade Name: MINOXIDIL Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): MINOXIDIL OTC/RX Status: RX Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval Original Abbreviated Application #: 075834 Tentative Approval Date: 30...
FDA Drug Approvals List August 2001 Active Ingredient(s): PREDNISONE OTC/RX Status: RX Original Abbreviated Application # 075733 Approval Date: 22-AUG-01 Trade Name: CLOBETASOL PROPIONATE Dosage Form: EMULSION, CREAM Applicant: STIEFEL LABORATORIES INC Active Ingredient(s): CLOBETASOL PROPIONATE OTC/RX Status: RX Original Abbreviated Application # 074911 Approval Date: 22-AUG-01 Trade Name: PHRENILIN Dosage Form:...
FDA Drug Approvals List July 2001 - Drug Approvals for July 2001 Definitions and Notes Original New Drug Applications Original Application #: 021064 Approval Date: 31-JUL-01 Trade Name: DEFINITY Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTION Applicant: DUPONT PHARMACEUTICALS CO Active Ingredient(s): PERFLUTREN LI MICROSPHERE OTC/RX Status: RX Indication(s): For the treatment patients with suboptimal...
Prescription and OTC Drug Product List 11/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL PERCOCET -A- + ENDO PHARMS 325MG;7.5MG N40434 001 NOV 23, 2001 NOV NEWA -A- + 325MG;10MG N40434 002 NOV 23, 2001 NOV NEWA ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE -A-...
withdrawn.PDF page 2
author: walshju
EVALUATION OF THE NEW YORK STATE ONECARD RX WORKERS COMPENSATION BENEFIT page 77
author: Julia Graffam
duplicates:http://www.quintiles.com/NR/rdonlyres/esnb6djlmpmd267ms6votav3bmvxowbn6p7p3tdm3hpo33qoowyjxa2dtx6ssx4tapmrkojnqv3rxjukkkphpf33g6c/1503.pdf
EVALUATION OF THE NEW YORK STATE ONECARD RX WORKERS COMPENSATION BENEFIT page 75
author: Julia Graffam
duplicates:http://www.quintiles.com/NR/rdonlyres/esnb6djlmpmd267ms6votav3bmvxowbn6p7p3tdm3hpo33qoowyjxa2dtx6ssx4tapmrkojnqv3rxjukkkphpf33g6c/1503.pdf
EVALUATION OF THE NEW YORK STATE ONECARD RX WORKERS COMPENSATION BENEFIT page 72
author: Julia Graffam
duplicates:http://www.quintiles.com/NR/rdonlyres/esnb6djlmpmd267ms6votav3bmvxowbn6p7p3tdm3hpo33qoowyjxa2dtx6ssx4tapmrkojnqv3rxjukkkphpf33g6c/1503.pdf
CDER Guidance Documents (Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) M2 Electronic Common Technical Document Specification [ HTML ] or [ PDF ] (Issued 6/2002, Posted 6/13/2002) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [ PDF ] M4 Common Technical Document--Quality: Questions and Answers...
