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/orange/appendix_a.txt 400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE EC-NAPROSYN, NAPROXEN ECONAZOLE NITRATE, ECONAZOLE NITRATE ECONOCHLOR, CHLORAMPHENICOL ECONOPRED PLUS, PREDNISOLONE ACETATE ECONOPRED, PREDNISOLONE ACETATE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID EDETATE DISODIUM, EDETATE DISODIUM EDEX, ALPROSTADIL EDROPHONIUM CHLORIDE PRESERVATIVE FREE, EDROPHONIUM...
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...
author: AUTHOR
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...
Specificity Table TOX.xls Tested (ng/ ml) Enteramine metabolite Serotonin metab.( Hydroxy (5) indole- 3- acetic acid) Serotonin metabolite 100,000 Ephedrine Ephedrine, d- Adrenergic 10,000,000 Ephedrine Ephedrine, l- Bronchodilator 10,000,000 MeAMP 400,000 Ephedrine metabolite Ephedrine, d- metab.( Norephedrine, d-) Ephedrine, d- metabolite 100,000 Epinine Deoxyepinephrine Vasoconstrictor 100,000 Epsom salts...
author: Biosite Incorporated
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt XX 4802 24-Jan-83 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA VERAPAMIL HCL 4813 06-Jan-83 PHARMACIA AND UPJOHN INC METHYLPREDNISOLONE ACETATE 4817 22-Feb-83 OMNICHEM NV (PRB) VERAPAMIL HCL 4827 03-Mar-83 REGIS CHEM CO "4-AMINOPYRIDINE REGIS CODE #002054-PROCESSED-MORTON GROVE, ILL FACILS" 4834 24-Feb-83 ERREGIERRE SPA CHENO DESOXYCHOLIC ACID 4839 11-Mar-83 MALLINCKRODT CHEMICAL...
Prescription and OTC Drug Product List 3/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 3: March 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CAPSULE; ORAL CHLORIDE; SODIUM ...
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 Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg, Rx Able Laboratories, IncButalbital, Acetaminophen, and Caffeine with Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg, Rx Vintage Pharmaceuticals, IncButalbital, Acetaminophen,...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls TEMAZEPAM DINAMITE DIPHARMA SPA METOCLOPRAMIDE HYDROCHLORIDE BP'80 DANISCO INGREDIENTS BUTALBITAL HOVIONE SOCIEDADE QUIMICA LDA BETAMETHASONE 17-VALERATE LABORATORIO CHIMICO INTERNATIONAL SPA CARISOPRODOL SOCIETA ITALIANA CORTICOSTEROIDI SPA DESONIDE AVENTIS PHARMA SA FLUOROMETHOLONE RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA BROMODIPHENHYDRAMINE HCL BULK COSMA SPA...
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
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 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:...
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 ...
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...
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration page 31
author: FDA
subject: 7/21/2000
6474-01 Butalbital page 2
author: John J. Carmody
6474-01 Butalbital page 1
author: John J. Carmody
http://www.fda.gov/cder/ob/docs/preface/ecbioava.htm 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; ORAL 325MG; 325MG; 50MG ACETAMINOPHEN; ASPIRIN; BUTALBITAL; CAFFEINE CAPSULE OR...
