http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 4Q2003 TYPE2ACTIVETEXT DMF # SUBMIT DATE HOLDER SUBJECT 131 01-Jan-40 CENTRAL SOYA SOYBEAN STEROL PRODUCTS 183 29-Feb-52 INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 191 24-Jan-56 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) 240 11-Jan-57 PHARMACIA & UPJOHN 19-NOR-ETHINYLTESTOSTERONE 281 21-Nov-57 UNIMED...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003 TYPE2ACTIVEEXCEL DMF # SUBMIT DATE HOLDER SUBJECT CENTRAL SOYA SOYBEAN STEROL PRODUCTS INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 MALLINCKRODT CHEMICAL INC PARZONE ...
Drug Approvals - A NDA 21-539 1/23/04 2/2/04 2/2/04 Acetaminophen Extended-release Tablets, 650 mg, OTC Coerpharma LLC ANDA 76-200 3/19/02 5/23/02 - - Acetaminophen Extended-release Tablets, 650 mg, OTC LAcetaminophen, Aspirin & Caffeine Tablets, 250 mg/250 mg/65 mg, OTC L
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, ...
1997 Abbreviated New Drug Applications (Generic Drugs) 040223 11/18/1997 3/27/1998 Acetaminophen, Caffeine and Dihydrocodeine Bitartrate capsules 356.4mg/30mg/16mg [2 MB] Mikart, Inc
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...
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-...
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- AB ANABOLIC 325MG...
Prescription and OTC Drug Product List 10/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE -D- AA MIKART 356.4MG;30MG;16MG N40109 001 AUG 26, 1997 OCT CRLD -A- + 356.4MG;30MG;16MG N40109 001 AUG 26, 1997 OCT CRLD DHC PLUS -D- AA + PURDUE FREDERICK 356...
Prescription and OTC Drug Product List 1/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 1: January 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - ACETAMINOPHEN, CAFFEINE, AND ...
FDA Drug Approvals List- April 1999 Original Application #: 050760 Approval Date: 15-APR-99 Trade Name: AMOXIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: SUSPENSION Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): AMOXICILLIN OTC/RX Status: RX Indication(s):For the use of Amoxil for oral suspension 200mg/5mL and 400mg/5mL in divided doses q12h Original Application #: 020924 Approval Date:...
40316LTR.PDF page 1
author: Unknown
Drug Approvals for August 1997 Drug Approvals for August 1997 Definitions and Notes August 1997 Original New Drug Applications Original Application #: 020808 Approval Date: 29-AUG-97 Trade Name: VISIPAQUE Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: NYCOMED INC Active Ingredient(s): IODIXANOL OTC/RX Status: RX Indication(s): Intra-arterial - for visceral intra-arterial digital...
http://www.fda.gov/cber/gdlns/anguidlst.txt Preliminary Guidance -------------------------------------------------------------------------------------------------------------------------------------------------------- Implementation Plan USP injection nomenclature October 2, 1995 Do Do -----------------------------------------------------------------------------------------------------------------------------------------------...
DDPA June 1995 20-238 TAGAMET HB SMITHKLINE BEECHAM CIMETIDINE 12-JUN-95 (TABLET) PARSIPPANY, NJ 100MG 07054 (HISTAMINE H2- RECEPTOR ANTAGONIST) (OTC) 20-398 PROPULSID JANSSEN CISAPRIDE MONOHYDRATE 13-JUN-95 (SUSPENSION) TITUSVILLE, NJ EQ 1MG BASE/ML 08560 EQ 2MG BASE/ML (UPPER GI TRACT MOTILITY STIMULATOR) 20-393 ATROVENT BOEHRINGER INGELHEIM IPRATROPIUM BROMIDE 22-JUN-95 (SPRAY, METERED)...
TOXICOLOGY PROFILES/COMBINATIONS - Volatiles Acetone Ethanol Isopropanol Methanol - Amphetamines Amphetamine (Dexedrine®) Ephedrine/Pseudoephedrine Methamphetamine (Desoxyn®) Phenmetrazine (Preludin®) Phentermine (Ionamin®) Phenylpropanolamine - *Antidepressants Amitriptyline (Elavil®) Doxepin (Adapin®, Sinequan®) Imipramine (Tofranil®) - *Barbiturates Amobarbital (Amytal®)...
Specificity Table TOX.xls Tested (ng/ ml) Solian Amisulpiride Antipsychotic 1,000,000 Soma Carisoprodol Muscle relaxant 100,000 Somnos Chloral hydrate Hypnotic 100,000 Somnos metabolite Chloral hydrate metab.( Trichloroethanol) Chloral hydrate metabolite 100,000 Somnurol Bromisovalum Sedative 5,000,000 Soneryl Butethal Barbiturate 100,000 BAR 50 Sorbol Sorbital Laxative 100,000 Sparine Promazine Antipsychotic...
author: Biosite Incorporated
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...
A5283.p65 Read the result between 3- 10 minutes Do not interpret the result after 10 minutes Cut- off 100- 200 ng/ ml Figure 3 Ctrl Band NEGATIVE Ctrl Band Ctrl Band INVALID POSITIVE Compounds not detected: Acetaminophen Ecgoninemethylether Phenobarbital Acetylsalicylic acid Ecgonine- HCL Phentermine Ampicillin Hydrochlorothiazide Phenycylidine Benzoic acid Indomethacin...
author: helen
A5283.p65 page 2
author: helen
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...
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL...
Prescription and Over-the-Counter Drug Product List: 12/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429...
ANDA Approvals - December 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - December 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 65-161 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP (CHEWABLE) 200 MG/28.5 MG (BASE) AND 400 MG/57 MG (BASE) - RANBAXY LABORATORIES LIMITED 12/3/2003- 2 76-656 FENOLDOPAM MESYLATE INJECTION, USP 10 MG...
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004 - - Pending - CYCLOBENZAPRINE HYDROCHLORIDE 7.5 MG - 03P-0461/CP1 ANABOLIC LABORATORIES - - Pending 10/1/2003- CLONAZEPAM 1 MG/5 ML - 03P-0464/CP1 LACHMAN CONSULTANT SERVICES - ORAL SOLUTION Pending 10/2/2003- HYDROCODONE BITARTRATE 5 MG ACETAMINOPHEN 325 MG - 03P-0475/CP1 INT'L REGULATORY BUSINESS CONS - LIQUID; ORAL Pending - ACETAMINOPHEN 770 MG, 385 MG ...
