http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W/ CODEINE, CODEINE...
Prescription and Over-the-Counter Drug Product List: 10/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML N40520 001 OCT 30, 2003 OCT NEWA TABLET; ORAL ANEXSIA >D> AA MALLINCKRODT 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA >A> AA 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA ALBUTEROL SULFATE TABLET...
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AP + WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC >A> @ 5,000 UNITS/VIAL N17055 001 JUN DISC >D> AP + 10,000 UNITS/VIAL N17055 002 JUN DISC >A> @ 10,000 UNITS/VIAL N17055 002 JUN DISC GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE >D> AB WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >A> AB + EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >D> WYTENSIN >D> AB WYETH...
author: AUTHOR
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
FDA Drug Approvals List July 1999 Drug Approvals for July 1999 Definitions and Notes Original New Drug Applications Original Application #: 021057 Approval Date: 29-JUL-99 Trade Name: ANTAGON Chemical Type: 1 Therapeutic Potential: P Dosage Form: INJECTABLE Applicant: ORGANON INC Active Ingredient(s): GANIRELIX ACETATE OTC/RX Status: RX Indication(s): Provides for the inhibition of premature LH surges in women...
Worthington Cholinesterase, Butyryl Cholinesterase, Butyryl ---- WBC Home ---- Manual/Protocol Index ---- Catalog Index Manual Page | Catalog Page I.U.B.: 3.2.1.81 Cholinesterase, Butyryl Acylcholine acylhydrolase Butyryl Cholinesterase Butyryl cholinesterase, (ButChE), catalyzes the hydrolysis of a number of choline esters: The enzyme is found in mammalian blood plasma, liver, pancreas, intestinal mucosa and the white...
Drug Information This information can be used by industry as an aid in developing drug products.- Major Drug Information Pages Accutane (Isotretinoin) Information Page Alimta (pemetrexed for injection) Information Page (2/5/2004) Analgesics: Safe Use of Over-the-Counter Pain Relievers (analgesics) and Fever Reducers (antipyretics) (1/22/2004) Avastin Information Page (2/26/2004) Baycol (cerivastatin)...
author: Carol Assouad
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US...
author: Susan Daugherty
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt IN ALABAMA" 9216 21-Jun-91 DIOSYNTH BV "PYRIDOSTIGMINE BROMIDE MFG
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls PHYTONADIONE, USP (VITAMIN K1) MANUFACTURED IN TOKYO, JAPAN AVENTIS PHARMA SA PREDNISOLONE USP MANUFACTURED IN PUTEAUX, FRANCE MAKOR CHEMICALS LTD DACTINOMYCIN CHUGAI PHARMACEUTICAL CO LTD SUCRALFATE CARAFATE TM GANES CHEMICALS INC PROPOXYPHENE NAPSYLATE, BULK FORM-MANUF CARLSTADT, NJ FACILITY LUSOCHIMICA S P A ISOXSUPRINE HYDROCHLORIDE FRANCO INDIAN PHARMACEUTICALS PVT LTD...
News Along the Pike December 2003 Issue FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - News Along the Pike January 5, 2003 Volume 9, Issue 6 Center for Drug Evaluation and Research PDF version for printouts Return to December 2003 News Along the Pike Center conducts Fall Honor Awards ceremony: 62 individuals, 39 groups recognized during November event By Jackie Barber...
ANDA Approvals - October 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - October 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-416 WARFARIN SODIUM TABLETS, USP 1 MG, 2 MG, 2.5 MG, 3 MG 4 MG, 5 MG, 6 MG, 7.5 MG, AND 10 MG - UPSHER-SMITH LABORATORIES, INC
Prescription and Over-the-Counter Drug Product List: 4/2003 45 -D- XCEL PHARMS 1MG/ML N05929 001 APR CFTG -A- AP + 1MG/ML N05929 001 APR CFTG -A- DIHYDROEROGTAMINE MESYLATE -A- AP PADDOCK 1MG/ML N40475 001 APR 28, 2003 APR NEWA DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL -A- TAZTIA XT -A- AB4 ANDRX PHARMS 120MG N75401 001 APR 10, 2003 APR NEWA -A- AB4 180MG N75401 002 APR 10, 2003 APR NEWA -A- AB4 240MG N75401 003 APR 10, 2003 APR...
author: AUTHOR
ANDA Approvals December 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - December 2002 - ANDA- Number Generic Drug Name Applicant Approval Date 1 65-116 BACITRACIN FOR INJECTION, USP 50,000 UNITS/VIAL AMERICAN PHARMACEUTICAL PARTNERS, INC
author: OGD
Prescription and Over-the-Counter Drug Product List: 2/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL -A- CODRIX -A- + ANDRX PHARMS 500MG;15MG N40447 001 FEB 26, 2003 FEB NEWA AZATHIOPRINE TABLET; ORAL AZASAN -A- AAIPHARMA LLC 25MG N75252 002 FEB 03, 2003 FEB NEWA -A- AB 50MG N75252 001 JUN 07, 1999 FEB NEWA -A- 75MG N75252 003 FEB 03, 2003 FEB NEWA -A- 100MG N75252 004 FEB 03, 2003...
author: AUTHOR
Pyridostigmine Bromide Questions and Answers Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Questions and Answers on- Pyridostigmine Bromide - What is the Food and Drug Administration (FDA) announcingPyridostigmine bromide is approved only for combat use by U.SPyridostigmine bromide appears to work by preventing Soman from blocking an enzyme...
author: AUTHOR
Pyridostigmine Bromide Drug Information Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Pyridostigmine Bromide FDA has approved pyridostigmine bromide to increase survival after exposure to the nerve agent SomanPyridostigmine bromide is approved only for combat use by U.SPyridostigmine Bromide ...
author: AUTHOR
ANDA Approvals April 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - April 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 76-391 ALBUTEROL SULFATE INHALATION SOLUTION 0.5% (BASE) NOVEX PHARMA 4/1/2003- 2 76-371 TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) AND 4 MG (BASE) BARR LABORATORIES, INC
author: OGD
FY 2003- Priority NDA Approvals FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -FY 2003- Priority NDA Approvals as of September 30, 2003 NDA # Trade Name -(Generic Name)- Dosage Form Applicant Approval Date Class Indication(s) 20-733 Suboxone (buprenorphine hydrochloride; naloxone hydrochloride dihydrate) Tablets Reckitt Benckiser 08-Oct-02 4PV Suboxone is indicated...
Prescription and OTC Drug Product List 12/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE TABLET; ORAL PRECOSE -D- BAYER 25MG N20482 004 MAY 29, 1997 DEC CAHN -D- 50MG N20482 001 SEP 06, 1995 DEC CAHN -D- + 100MG N20482 002 SEP 06, 1995 DEC CAHN -A- BAYER PHARMS 25MG N20482 004 MAY 29, 1997 DEC CAHN -A- 50MG N20482 001 SEP 06, 1995 DEC CAHN -A- + 100MG N20482 002 SEP 06, 1995 DEC CAHN ACYCLOVIR -A- CREAM;...
News Along the Pike Jan-Feb 2003 News Along the Pike, February 21, 2003 1 FDA Science Forum to focus on protecting public health D on't miss the 9th Annual FDA Science Forum, "FDA Science: Protecting America's Health." This premiere scientific event will be held April 24 and 25 at the new Washington Convention Center
author: Food and Drug Administration
subject: Center for Drug Evaluation and Research
News Along the Pike Jan-Feb 2003 page 7
author: Food and Drug Administration
subject: Center for Drug Evaluation and Research
http://www.fda.gov/cder/foi/label/2003/20414_pyridostigminebromide_lbl.pdf Army Medical Research and Materiel Command (MCMR- RCQ- RA) 504 Scott Street Fort Detrick, MD 21702- 5012 Package Insert Revised [month/ day/ year] Pyridostigmine Bromide Patient Package Insert page 1 Important Information Rx Only February, 2003 Pyridostigmine Bromide (PB) 30 mg Protection Against Chemical Warfare Agents Pyridostigmine bromide is approved...
http://www.fda.gov/cder/foi/label/2003/20414_pyridostigminebromide_lbl.pdf page 17
duplicates:http://www.fda.gov/cder/foi/label/2003/020414lbl.pdf
http://www.fda.gov/cder/foi/label/2003/20414_pyridostigminebromide_lbl.pdf page 16
duplicates:http://www.fda.gov/cder/foi/label/2003/020414lbl.pdf
