New Topics Obstetrics Case Management for High-Risk Pregnancy Enoxiparin (Lovenox) and its Safety in Pregnancy External Cephalic Version for the Management of Breech Presentation Fibrin Sealant for Treatment of Preterm Premature Rupture of Membrane (PROM) In Utero Surgical Treatment for Congenital Cystic Adenomatoid Malformation In Utero Surgical Treatment for Fetal Diaphragmatic Hernia In...
1996 and Older - New Drug Application (NDA) New Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
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 ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
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 Army 3 P 05-Feb-03...
author: Susan Daugherty
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt LISINOPRIL CRUDE AS MFG IN COURBEVOIE AND HAM FRANCE 14537 19-Nov-99 FUJISAWA PHARMACEUTICAL CO LTD FK8453 DRUG SUBSTANCE AS MFG IN HYOGO AND OSAKA JAPAN 14538 09-Nov-99 SICOR DE MEXICO SA DE CV AMCINONIDE AS MFG IN LERMA MEXICO 14539 18-Nov-99 "UQUIFA ITALIA, S.P.A." CLINDAMYCIN HYDROCHLORIDE USP AS MFG IN MILAN ITALY 14540 18-Nov-99 DIOSYNTH BV TESTOSTERONE UNDECANOATE AS MFG IN...
02-1088_VIaDUR Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Viadur (Leuprolide Acetate Implant Company:--ALZA Corporation Application No.:--21-088 Approval Date:-3/3/2000 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Chemistry Review(s) - Environmental Assessment - Pharmacology Review(s) - Statistical Review(s) -...
author: Paul Stauffer
20-708S011_Lupron.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Lupron Depot-3 Month (Leuprolide Acetate) Company:--TAP Pharmaceuticals Products, Inc
author: Paul Stauffer
20-011S011 Lupron Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Lupron Depot (Leuprolide Acetate) Company:--TAP Pharmaceuticals Products, Inc
author: Paul Stauffer
21-343_Eligard (Leuprolide Acetate) Injectable Suspension Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Eligard (Leuprolide Acetate) Injectable Suspension Company:--ATRIX Laboratories, Inc
author: Paul Stauffer
../2002/21-379_Eligard_ Food and Drug Administration • Center for Drug Evaluation and Research Title Search Eligard (Leuprolide Acetate) Injection Company:--Atrix Laboratories, Inc
author: USERNAME
ANDAs Approvals - October 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals - October 2000 Page: 1 1
author: USERNAME
ANDA Approvals November 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - November 2001 - - ANDA Number Drug Name Applicant Approval Date 1 75-916 RIMANTADINE HYDROCHLORIDE TABLETS 100 MG COREPHARMA LLC 11/2/01 2 75-682 IBUPROFEN TABLETS, USP 400 MG, 600 MG, AND 800 MG BASF CORPORATION 11/14/01 3 75-347 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG,...
author: USERNAME
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
20011-s014_Lupron.htm & 20708-S003 Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Lupron (Leuprolide Acetate) Depot 3.75mg & 11.25mg Company:- TAP Holdings Inc
author: Paul Stauffer
Efficacy Supplements Approved in Calendar Year 1998 DESMOPRESSIN ACETATE RHONE POULENC RORER 19-955 26-Mar-97 25-Mar-98 SE1 12.0 Primary nocturnal enuresisACETATE WYETH AYERST LABS 20-527 09-Jan-97 09-Jan-98 SE2 12.0 Treatment of moderate to severe vasomotor symptoms associated with the menopause; treatment of vulvar and vaginal atrophy; prevention of osteoporosis
author: Brenda Harmon
http://www.repromed.com.au/DOCUMENTS/statement.pdf Information Statement Table of Contents i Welcome to 1 Out of Hours Contact 1 Legal Aspe 2 Health and 4 Counselling and Support 5 Medications 6 Ovulation 8 Intra Uterine Insemination 10 Donor Sperm Program (DI) 12 IVF, ICSI Treatment 13 § How many eggs to be Inseminated
FDA Drug Approvals List November 2001 REDDY'S LABORATORIES LIMITED Active Ingredient(s): IBUPROFEN OTC/RX Status: RX Original Abbreviated Application # 075347 Approval Date: 16-NOV-01 Trade Name:OMEPRAZOLE Dosage Form: CAPSULE Applicant: ANDRX PHARMACEUTICALS, INC Active Ingredient(s): OMEPRAZOLE OTC/RX Status: RX Original Abbreviated Application # 075682 Approval Date: 14-NOV-01 Trade Name:IBU Dosage Form: TABLET...
FDA Drug Approvals List September 2001 - Drug Approvals for September 2001 Definitions and Notes Original New Drug Applications Original Application #: 021279 Approval Date: 25-SEP-01 Trade Name: FORADIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: POWDER, FOR INHALATION Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): FORMOTEROL FUMARATE OTC/RX Status: RX Indication(s): For the long-term, twice...
FDA Drug Approvals List August 2001 JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): COPPER OTC/RX Status: RX Application #:018612 Labeling Supplement#: 026 To Original New Drug Application Approval Date: 24-AUG-01 Trade Name: NICORETTE Dosage Form: GUM, CHEWING Applicant: SMITHKLINE BEECHAM CONSUMER HEALTHCARE LP Active Ingredient(s): NICOTINE POLACRILEX OTC/RX Status: RX Application #: 014879 Labeling...
FDA Drug Approvals List March 2001 Original Application #: 021082 Approval Date: 01-MAR-01 Trade Name: TAVIST ALLERGY/SINUS/HEADACHE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: NOVARTIS CONSUMER HEALTH INC Active Ingredient(s): ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE OTC/RX Status: OTC Indication(s): For temporary relief of symptoms associated with hay fever,...
FDA Drug Approvals List July 2002 - Drug Approvals for July 2002 Definitions and Notes Original New Drug Applications Original New Drug Application # 021409 Approval Date: 26-JUL-02 Trade Name: SINGULAIR Chemical Type: 3 Therapeutic Potential: S Dosage Form: GRANULE Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC Active Ingredient(s): MONTELUKAST SODIUM OTC/RX Status: RX Indication of Use: PROPHYLAXIS/CHRONIC...
FDA Drug Approvals List April 2002 JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): HALOPERIDOL OTC/RX Status: RX Application #: 011340 Labeling Supplement #: 016 To Original New Drug Application Approval Date: 17-APR-02 Trade Name: CERUMENEX Dosage Form: SOLUTION Applicant: PURDUE FREDERICK CO Active Ingredient(s): TRIETHANOLAMINE POLYPEPTIDE OLEATE CONDENSATE OTC/RX Status: OTC Application #: 010596...
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;50MG;40MG;30MG...
Prescription and OTC Drug Product List 6/2002 ACTHAR GEL -D- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 JUL DISC -A- @ 40 UNITS/ML N08372 006 JUL DISC DIATRIZOATE SODIUM SOLUTION; ORAL, RECTAL HYPAQUE -D- AMERSHAM HLTH 40% N11386 003 JUL DISC -A- @ 40% N11386 003 JUL DISC DICLOFENAC SODIUM GEL; TOPICAL SOLARAZE -A- + BIOGLAN PHARMA 3% N21005 001 OCT 16, 2000 JUL CAHN -D- + BIOGLAN PHARMA PLC 3% N21005 001 OCT 16, 2000 JUL CAHN...
