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 Ventolin Albuterol...
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 001 SEP 10, 2003 DEC CTNA...
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...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 VENLAFAXINE HYDROCHLORIDE WYETH AYERST 20-699 SE1 022 12-Sep-01 11-Feb-03 17.0 Provides for the use of Effexor XR (venlafaxine hydrochloride) Extended-release Capsules for the treatment of social anxiety disorder as a new indication
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt IN JAPAN 8965 05-Feb-91 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA "ATENOLOL MANUFACTURED IN LATINA, ITALY." 8967 15-Feb-91 GANES CHEMICALS INC "VENLAFAXINE HYDROCHLORIDE AS MFGVENLAFAXINE HYDROCHLORIDE AS MFGVENLAFAXINE HYDROCHLORIDE, MANUFACTURED IN AVRILLE CEDEX, FRANCE" 12348 31-Jan-97 ANTIBIOTICOS SA "6-AMINO PENICILLANIC ACID,...
http://www.fda.gov/cder/dmf/text/4Q2003NEWTEXT.txt CHINA." 16892 V 3-Sep-2003 ALTHEA TECHNOLOGIES INC "ASEPTIC FORMULATION, FILL, AND FINISH FACILITY IN SAN DIEGO, CA." 16893 III 15-Sep-2003 ERIE MOLDED PLASTICS INC "LID FOR DEODORANT AS MANUFACTURED IN ERIE, PA." 16894 II 5-Oct-2003 DIVIS LABORATORIES LTD "LEVITERACETAM AS MANUFACTURED IN ANDHRA PRADESH, INDIA." 16895 IV 6-Oct-2003 FIRMENICH INC "NATURAL & ARTIFICIAL ORANGE FLAVOR...
http://www.fda.gov/cder/dmf/xls/4Q2003NEWEXCEL.xls II RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA SERTRALINE HYDROCHLORIDE FORM II AS MANUFACTURED IN CAMPOVERDE DI APRILIA (LT), ITALYHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA II NICHOLAS PIRAMAL INDIA LTD ITRACONAZOLE AS MANUFACTURED IN ANDHRA...
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...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004 - CAPSULE; ORAL Withdrawn 7/31/2001- SODIUM TETRADECYL SULFATE 0.5% & 0.2% - 01P-0351/CP1 Bennett and Company - INJECTION Denied 4/12/2002- TESTOSTERONE 5% - 01P-0302/CP1 Testocream LLC - GEL; TOPICAL Denied 4/12/2002- THIOTEPA, STERILE 30 MG/VIAL - 00P-0092/CP1 GENSIA SICOR - FOR INJECTION Approved 6/14/2000- TRIPELENNAMINE HYDROCHLORIDE 25 MG/5 ML DEXTROMETHORPHAN...
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;30MG N40441 001...
author: AUTHOR
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_DEC_1998.HTML 9-Dec-1998 TRIDIL INJECTION Nitroglycerine Injection 18-537 S-015 Faulding 9-Dec-1998 EFFEXOR Venlafaxine Hydrochloride 20-151 S-009 Wyeth Ayerst 9-Dec-1998 NITROGLYCERIN IN DEXTROSE Nitroglycerin 19-970 S-009 Baxter Hlthcare 9-Dec-1998 REBETOL Interferon Alfa-2b, Recombinant Capsules 20-903 S-002 Schering Plough Res 9-Dec-1998 BRETHINE INJECTION Terbutaline Sulfate...
FDA Drug Approvals List May 2001 Pylori eradication to reduce the risk of duodenal ulcer recurrence, maintenance of healed duodenal ulcers, short-term treatment of active benign gastric ulcer, short-term treatment of symptomatic gastroesophageal reflux disease (GERD), short-term treatment of erosive esophagitis, maintenance of healing of erosive esophagitis, and pathological hypersecretory conditions including...
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...
withdrawn.PDF page 3
author: walshju
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...
Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 37
author: FDA
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration page 33
author: FDA
subject: 7/21/2000
ranbaxy - - - - - - You are here :- Home - Products - - Dosage Forms - INDIA DOSAGE FORMS LIST- (Updated Jan 2002) Anti-infectives G.I. & Nutritionals CVS & Diabetes CNS NSAID & related Anti-allergants ...
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Efficacy Supplements Approved in Calendar Year 2001 (SE1-SE7 AND SE8S) VENLAFAXINE HCL WYETH AYERST LABS 20-151 19-May-00 2-May-01 SE1 017 N 11.4 Provides for the use of Effexor Tablets for the prevention of recurrence of depression and for the prevention of relapse of depressionVENLAFAXINE HCL WYETH AYERST LABS 20-151 22-May-00 2-May-01 SE1 018 N 11.3 Provides for the use of Effexor Tablets for the prevention of recurrence of depression...
author: Darlene Norris
ranbaxy - - - - - - You are here : Home - Products - - APIs GLOBAL API Active Pharmaceutical Ingredients(API) Ranbaxy's Global API business is a combination of commodity and technology products operating in regulated ...
Prescription and OTC Drug Product List October 1997 Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 10: Jan '97 - Oct '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE; ORAL OXYCODONE AND ACETAMINOPHEN...
Drug Approvals for May 1997 orbiculare) Application #:020297Efficacy Supplement#:001 Type: SE1 to Original New Drug Application Approval Date: 29-MAY-97 Trade Name: COREG Dosage Form: TABLET Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): CARVEDILOL OTC/RX Status: RX Efficacy Claim: For the new indication of congestive heart failure and a new dosage strength of 3.125 mg Application #...
FDA Drug Approvals List- March 1999 Drug Approvals for March 1999 Definitions and Notes March 1999 Original New Drug Applications Original Application #: 020966 Approval Date: 30-MAR-99 Trade Name: SPORANOX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON Active Ingredient(s): ITRACONAZOLE OTC/RX Status: RX Indication(s): For the treatment of...
