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A9053 Paroxetine page 1
author: Twin 450
What's new at CDER by Date Adult (Multi-Vitamins for Infusion), aaiPharma Ciprofloxacin Injecition USP, American Pharmaceutical, Tentative Approval Mitoxantrone Injection, Bedford Laboratories, Tentative Approval Modafinil Tablets, Ranbaxy Laboratories, Tentative Approval Paroxetine Hydrochloride Tablets, Sandoz, Inc., Tentative Approval Office of Biostatistics; Organization and Responsibilities ...
author: Paul Stauffer
Office of Generic Drugs: News, Announcements and Federal Register Notices from 2002 FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Office of Generic Drugs:- Previous News, Announcements and Federal Register Notices News and Announcements Suggestions for Improving "Controlled Correspondence" to the Office of Generic DrugsParoxetine Hydrochloride Tablets [ HTML...
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...
http://www.fda.gov/cder/orange/appendix_a.txt SODIUM, AMINOSALICYLATE SODIUM PACERONE, AMIODARONE HYDROCHLORIDE PACLITAXEL, PACLITAXEL PAGITANE, CYCRIMINE HYDROCHLORIDE PAMELOR, NORTRIPTYLINE HYDROCHLORIDE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PAMINE FORTE, METHSCOPOLAMINE BROMIDE PAMINE, METHSCOPOLAMINE BROMIDE PANCURONIUM BROMIDE, PANCURONIUM BROMIDE PANCURONIUM, PANCURONIUM BROMIDE PANDEL,...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 PAROXETINE HYDROCHLORIDE GLAXOSMITHKLINE 20-936 SE1 011 26-Jun-02 28-Aug-03 14.1 Provides for the use of Paxil CR in the treatment of premenstrual dysphoric disorder (PMDD)PAROXETINE HYDROCHLORIDE GLAXOSMITHKLINE 20-936 SE1 012 20-Dec-02 16-Oct-03 9.9 Provides for the use of Paxil CR (paroxetine hydrochloride) Controlled-release Tablets for the treatment...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt MELOXICAM JETMILLED AS MFG IN BIBERACH/RIB GERMANY 14432 30-Sep-99 ASAHI GLASS CO LTD PAROXETINE HYDROCHLORIDE AMORPHOUS AS MANUFACTURED IN ICHIHARA CITY CHIBA JAPAN 14436 05-Oct-99 FERMIC SA DE CV CLAVULANATE POTASSIUM AS MANUFACTURED IN MEXICO CITY MEXICO 14437 05-Oct-99 CIPLA LTD SERTRALINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA 14439 23-Jun-99 SANYO...
../2002/20-936S-008_Paroxetine Hydrochloride Food and Drug Administration • Center for Drug Evaluation and Research Title Search Paxil CR (Paroxetine Hydrochloride) Controlled-Release Tablests Company:--GlaxoSmithKline Application No.:--20-982 & 20-936/S8 Approval Date:-2/12/2002 Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Chemistry Review(s) - Pharmacology Review(s) -...
author: USERNAME
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004 - CAPSULE; ORAL Withdrawn 7/31/2001- PAROXETINE 20 MG & 40 MG - 01P-0241/CP1 CIPHER PHARMACEUTICALS LTD
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004 - CREAM; TOPICAL Denied 7/3/2002- LOPERAMIDE HYDROCHLORIDE 1 MG - 02P-0424/CP1 BANNER PHARMACAPS - CAPSULE; ORAL Approved 4/14/2003- LOPERAMIDE HYDROCHLORIDE 2 mg - 02P-0380/CP1 BANNER PHARMACAPS - SOFT GELATIN CAPSULES Pending - MERCAPTOPURINE 100 MG - 00P-1645/CP1 McKENNA & CUNEO - TABLET; ORAL Approved 4/17/2001- METFORMIN HYDROCHLORIDE 1000 MG - 03P-0388/CP1...
First-Time Generics - July 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -First-Time Generics - July 2003 - Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 GANCICLOVIR SODIUM FOR INJECTION-500 MG (BASE)/VIAL------- BEDFORD LABORATORIES CYTOVENE-IV FOR INJECTION 7/16/2003- 2 CALCITRIOL ORAL SOLUTION-1 MCG/ML------- ROXANE LABORATORIES, INC
Prescription and Over-the-Counter Drug Product List: 7/2003 >A> @ FERRING 5,000 UNITS/VIAL N17055 001 JUL CAHN >A> @ 10,000 UNITS/VIAL N17055 002 JUL CAHN >A> @ 20,000 UNITS/VIAL N17055 003 JUL CAHN >D> @ WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUL CAHN >D> @ 10,000 UNITS/VIAL N17055 002 JUL CAHN >D> @ 20,000 UNITS/VIAL N17055 003 JUL CAHN GRANISETRON HYDROCHLORIDE SOLUTION; ORAL KYTRIL >D> @ ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27,...
author: AUTHOR
ANDA Tentative Approvals -May 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - May 2001 - ANDA Number Drug Name Applicant Tentative Approval Date 1 75-410 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MG KREMERS URBAN DEVELOPMENT COMPANY 5/3/01 2 75-521 BUSPIRONE HYDROCHLORIDE TABLETS USP 5 MG, 10 MG, AND 15 MG TORPHARM 5/9/01 3 75...
author: USERNAME
20-936_Paxil.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Paxil CR (Paroxetine Hydrochloride) Company:- Smith Kline Beecham Application No.:- 020936 Approval Date:-2/16/99 - Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Chemistry Review(s) - Pharmacology Review(s) Statistical Review(s) - Clinical...
author: Paul Stauffer
rld_labeling_approved_may_1999 Firm Date ISUPREL Isoproterenol Hydrochloride Injection 10-515 S-022 Abbott 4-May-1999 PATINOL /PLATINOL-AQ Cisplatin For Injection/Cisplatin Injection 18-057 S-068 Bristol Myers Squibb 5-May-1999 MAXAQUIN Lomefolxacin Hydrochloride 20-013 S-013 Searle 6-May-1999 URACIL MUSTARD Uracil Mustard capsules 12-892 S-001 Roberts Labs 6-May-1999 ESTROSTEP Norethindrone acetate...
FDA Drug Approvals List June 2001 PERRIGO COMPANY Active Ingredient(s): MONOXIDIL OTC/RX Status: RX Original Abbreviated Application # 075750 Approval Date: 8-JUN-01 Trade Name: DOXAZOSIN MESYLATE Dosage Form: TABLET Applicant: SIDMAK LABORATORIES, INC Active Ingredient(s): DOXAZOSIN MESYLATE OTC/RX Status: RX Original Abbreviated Application # 075502 Approval Date: 05-JUN-01 Trade Name: CLOTRIMAZOLE AND...
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...
FDA Drug Approvals List April 2001 - Drug Approvals for April 2001 Definitions and Notes Original New Drug Applications Original Application #: 020949 Approval Date: 30-APR-01 Trade Name: ACCUNEB Chemical Type: 5 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: DEY LABORATORIES INC Active Ingredient(s): ALBUTEROL SULFATE OTC/RX Status: RX Indication(s): For the treatment of asthma-related bronchospasm in...
FDA Drug Approvals List February 2001 Approvable Original New Drug Applications - Original Abbreviated New Drug Applications Original Abbreviated Application # 075402 Approval Date: 28-FEB-01 Trade Name: METAPROTERENOL SULFATE Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): METAPROTERENOL SULFATE OTC/RX Status: RX Original Abbreviated Application # 075403 Approval Date: 28-FEB-01 Trade Name:...
FDA Drug Approvals List February 2002 Active Ingredient(s): BUSPIRONE HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application#065022 Approval Date: 27-FEB-02 Trade Name: BACITRACIN ZINC AND POLYMYXIN B SULFATE Dosage Form: OINTMENT Applicant: ALTANA INC Active Ingredient(s): BACITRACIN ZINC; POLYMYXIN B SULFATE OTC/RX Status: RX Original Abbreviated Application# 075874 Approval Date: 26-FEB-02...
Prescription and OTC Drug Product List 10/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;7.5MG N40464 001 OCT 23, 2002 OCT NEWA -A- AA 325MG;10MG N40464 002 OCT 23, 2002 OCT NEWA -A- AA 650MG;10MG N40476 001 OCT 23, 2002 OCT NEWA -A- AA 750MG;7.5MG N40469 001 OCT 25, 2002 OCT NEWA -A- AA MALLINCKRODT 750MG...
ANDA Macdonald: This is in reference to your abbreviated new drug application (ANDA) dated March 31, 1998, submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (the Act) for Paroxetine Hydrochloride Tablets 10 mg, 20 mg, 30 mg, and 40 mgParoxetine Hydrochloride Tablets 180-day Exclusivity 1 The referenced...
author: EDickinson
Shared Exclusivity for Paroxetine Hydrochloride Tablets FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER Shared Exclusivity for Paroxetine Hydrochloride Tablets ANDA 75-356 July 30, 2003 Apotex Corporation Attention: Marcy Macdonald U.SParoxetine Hydrochloride Tablets Shared exclusivity applies to Paroxetine Hydrochloride ANDAs because...
http://www.fda.gov/cder/foi/appletter/2003/75356ap.pdf Agent for: TorPharm 616 Heathrow Drive Lincolnshire, IL 60069 Dear Madam: This is in reference to your abbreviated new drug application (ANDA) dated March 31, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (the Act), for Paroxetine Hydrochloride Tablets, 10 mg (base), 20 mg (base), 30 mg (base), and 40 mg (base)
