http://www.fda.gov/cder/orange/appendix_a.txt RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLAGYL I.V., METRONIDAZOLE HYDROCHLORIDE FLAGYL, METRONIDAZOLE FLAREX, FLUOROMETHOLONE ACETATE FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE FLAVOXATE HCL, FLAVOXATE HYDROCHLORIDE FLAXEDIL, GALLAMINE TRIETHIODIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE FLEXICORT, HYDROCORTISONE FLOLAN, EPOPROSTENOL SODIUM...
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...
Drug Approvals - D Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted DMSA (Kit for the preparation of Tc99m Succimer for Injection), Rx Amersham Health NDA 17-944/S-018 11/24/03 11/25/03 - - Dacarbazine for Injection USP, 200 mg/vial, Rx Faulding Pharmaceutical Co
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 PHARMACEUTICALS INC 2 HYDROXY...
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 BITARTRATE ...
19-452S017_Derma Smoothe Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Derma-Smoothe/FS (Fluocinolone Acetonide) Topical Oil Company:--Hill Dermaceuticals, Inc
author: Paul Stauffer
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004 - INJECTION Approved 8/13/2003- METHADONE HYDROCHLORIDE 15MG,20MG,30MG,40MG - 03P-0119/CP1 LACHMAN CONSULTANT SERVICES - TABLETS USP Pending 5/13/2003- VENLAFAXINE HYDROCHLORIDE 37.5MG, 75MG, 150MG - 03P-0159/CP1 LACHMAN CONSULTANT SERVICES - EXTENDED RELEASE TABLETS Pending 4/16/2003- DIVALPROEX SODIUM 1000 MG - 03P-0178/CP1 LACHMAN CONSULTANT SERVICES - EXTENDED RELEASE TABLETS...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004 FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -OGD Suitability Tracking Report (Sorted by Drug Name) as of 1/5/2004 Drug/Strength Petition No/Firm Dosage Form Status Status Date ACETAMINOPHEN 200MG;200MG; 200MG HYDROCODONE BITARTRATE 5MG;7.5MG;10MG - 02P-0004/CP1 SHOTWELL AND CARR, INC
2086PadSec12-2.qxd Secundum Artem VOLUME 12 NUMBER 2 Current & Practical Compounding Information for the Pharmacist
author: Mercury
2086PadSec12-2.qxd page 4
author: Mercury
RLD_LABELING_ APPROVED_AUG_1999 Product Name Drug Name NDA No Supp.No Firm Date LARIAM Mefloquine HCl Tablets 19-591 S-012 Roche 02-Aug-1999 PROSCAR Finasteride Tablets 20-180 S-018 Merck 02-Aug-1999 CEFOTAN Cefatetan Disodium 50-588 S-026 Zeneca 05-Aug-1999 MARINOL Dronabinol Capsules 18-651 S-011 Unimed 05-Aug-1999 ZOCOR Simvastatin Tablets 19-766 S-032 Merck 05-Aug-1999 GLUCOTROL Glipizide Tablets 17-783 S-015...
FDA Drug Approvals List October 2001 - Drug Approvals for October 2001 Definitions and Notes Original New Drug Applications Original Application #: 021356 Approval Date: 26-OCT-01 Trade Name: VIREAD Chemical Type: 1 Therapeutic Potential: P Dosage Form: TABLET Applicant: GILEAD SCIENCES INC Active Ingredient(s): TENOFOVIR DISOPROXIL FUMARATE OTC/RX Status: RX Indication(s): For use in combination with other...
19452S15_DermaSmooth.htm Derma-Smoothe/FS (Fluocinolone Acetonide Topical Oil) Food and Drug Administration • Center for Drug Evaluation and Research Approval Package [http://internet-dev/cder/templates/2ndrow-component.htm] [http://internet-dev/cder/templates/sidebar-component.htm] Derma-Smoothe/FS (Fluocinolone Acetonide Topical Oil) Company:- Hill Dermaceuticals, Inc
author: Paul Stauffer
Prescription and OTC Drug Product List 6/2002 45 -D- + NOVARTIS 1MG/ML N05929 001 JUN CAHN -A- XCEL PHARMS 1MG/ML N05929 001 JUN CAHN DILTIAZEM HYDROCHLORIDE INJECTABLE; INJECTION CARDIZEM -D- AP + AVENTIS PHARMS 5MG/ML N20027 001 OCT 24, 1991 JUN CAHN -D- + 25MG/VIAL N20027 003 AUG 18, 1995 JUN CAHN -A- AP + BIOVAIL 5MG/ML N20027 001 OCT 24, 1991 JUN CAHN -A- + 25MG/VIAL N20027 003 AUG 18, 1995 JUN CAHN DILTIAZEM MALATE;...
Prescription and OTC Drug Product List 1/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA KV PHARM 500MG/15ML;7.5MG/15ML N40366 001 JAN 23, 2002 JAN NEWA AMPHOTERICIN B INJECTABLE, LI COMPLEX; INJECTION ABELCET -A- + ELAN PHARMS 5MG/ML N50724 001 NOV 20, 1995 JAN CAHN -D- + LIPOSOME 5MG/ML N50724 001 NOV 20, 1995 JAN...
Farmacie Petrone Pharmaceuticals Supply HYALECTIN), ACIDO IOPANOICO, ACIDO IOTALAMICO (SALE DI MEGLUMINA), ACIDO IOTALAMICO (SALE SODICO), ACIDO IOXAGLICO (SALE SODICO, ACIDO LATTICO, ACIDO LINOLEICO, ACIDO MA, ACIDO MALICO, ACIDO MECLOFENAMICO, ACIDO MECLOFENAMICO (SALE SODICO), ACIDO MEFENAMICO, ACIDO NALIDIXICO, ACIDO NIFLUMICO, ACIDO OROTICO, ACIDO PALMITICO, ACIDO PAMIDRONICO (SALE DISODICO), ACIDO PIPEMIDICO, ACIDO...
Laboratorios Raslafar Spanish company dedicated in commercialization of chemical-pharmaceutical products for all over the world ...
author: Rasfer Internacional, S.A.
Efficacy Supplements Approved in Calendar Year 2001 (SE1-SE7 AND SE8S) EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2001 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2001 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIORITY REVIEW- TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION 13 C-UREA MERETEK 20-586 10-Jul-00 10-May-01 SE2 004 N 10.0 Provides for a decrease in dose of 13 C-urea...
author: Darlene Norris
Prescription and OTC Drug Product List 10/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 10: October 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE BENZYL PENICILLOYL-POLYLYSINE CAPSULE; ORAL INJECTABLE; INJECTION BUTALBITAL, ACETAMINOPHEN AND CAFFEINE PRE-PEN - ADD - AB WEST WARD 500MG;50MG;40MG N40261...
Prescription and OTC Drug Product List 12/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 12: December 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE - ADD - BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE TABLET; ORAL - ADD - GEL; TOPICAL OXYCODONE AND ACETAMINOPHEN - ADD - BENZACLIN - ADD - AA WATSON LABS...
Prescription and OTC Drug Product List 5/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 5: January-May 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE - ADD - ALMOTRIPTAN MALATE CAPSULE; ORAL - ADD - TABLET; ORAL ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE - ADD - AXERT - DLT - + MIKART 150MG;180MG...
http://www.fda.gov/cder/rdmt/escy99ap.htm EFFICACY SUPPLEMENTS APPROVED IN CY 99 GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIOITY REVIEW TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION - - - - - - - - - - ATOVAQUONE GLAXO WELLCOME 20-500 03/06/98 01/05/99 SE1 5 N 10.0 Prevention of Pneumocystis carinii pneumonia (PCP)
author: Darlene
FARMACIE PETRONE S.r.l. - NAPOLI ITALY HYALECTIN), ACIDO IOPANOICO, ACIDO IOTALAMICO (SALE DI MEGLUMINA), ACIDO IOTALAMICO (SALE SODICO), ACIDO IOXAGLICO (SALE SODICO, ACIDO LATTICO, ACIDO LINOLEICO, ACIDO MA, ACIDO MALICO, ACIDO MECLOFENAMICO, ACIDO MECLOFENAMICO (SALE SODICO), ACIDO MEFENAMICO, ACIDO NALIDIXICO, ACIDO NIFLUMICO, ACIDO OROTICO, ACIDO PALMITICO, ACIDO PAMIDRONICO (SALE DISODICO), ACIDO PIPEMIDICO, ACIDO...
FDA Drug Approvals List August 1999 Original Application #: 020997 Approval Date: 05-AUG-99 Trade Name: CHIROCAINE Chemical Type: 2 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: DARWIN DISCOVERY LTD Active Ingredient(s): LEVOBUPIVACAINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For surgical anesthesia and pain management for adults Original Application #: 020902 Approval Date: 05-AUG-99 Trade Name:...
Drug and Device Approvals March 1995 74-322 CAPTOPRIL NOVOPHARM CAPTOPRIL 20-MAR-95 (TABLET) WILSON, NC 12.5MG 27396 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) 74-434 CAPTOPRIL MYLAN CAPTOPRIL 22-MAR-95 (TABLET) MORGANTOWN, WV 12.5MG 26505 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) 74-451 CAPTOPRIL ROYCE LABS CAPTOPRIL 31-MAR-95 (TABLET) MIAMI, FL 12.5MG 33014 25MG 50MG 100MG (ANGIOTENSIN...
