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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,...
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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
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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
Application No.:--21-343 Approval Date:-1/23/2002 - Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Chemistry Review(s) - Pharmacology Review(s) -...
author: Paul Stauffer
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../2002/21-379_Eligard_
Food and Drug Administration • Center for Drug Evaluation and Research Title Search Eligard (Leuprolide Acetate) Injection Company:--Atrix Laboratories, Inc
Application No.:--21-379 Approval Date:-7/24/2002 Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Chemistry Review(s) - Pharmacology Review(s) - Microbiology Review(s) -...
author: USERNAME
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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
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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...
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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...
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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...
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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...
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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...
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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
20195/S-002 5/20/96 8/2/99 Fragmin/dalteparin sodium Injection [1.5 MB] Pharmacia and Upjohn 020287/S005 9/24/1996 2/4/1998 Heptolite, Kit for the Preparation of Technetium Tc 99m Disofenin Merck 18467/ S-13 & S-14 12/29/1993 8/5...
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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...
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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...
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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
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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
Application No.:--20-708/S011 Approval Date:-9/21/01 - Approval Letter(s) - Printed Labeling - Medical Review(s) Part 1 Part 2 - Part 3 - Statistical Review(s) - Clinical Pharmacology...
author: Paul Stauffer
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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
Application No.:--20-011/S021 Approval Date:-9/21/01 - Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Part 3 - Clinical Pharmacology Biopharmaceutics Review(s) - -...
author: Paul Stauffer
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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
10/2/00 ACETAMINOPHEN CAPSULES, USP 5 MG/500 MG 2
75-468 CLONAZEPAM TABLETS, USP TORPHARM 10/6/00 0.5 MG, 1 MG, 2 MG 4
75-426 DOXAZOSIN MESYLATE CHELSEA LABORATORIES, INC
10/18/00 TABLETS, 1 MG (BASE,) 2 MG ...
author: USERNAME
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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
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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
Application No.:- 20-011/S014 & 20-708/S003 Approval Date:-4/9/1998 - Approval Letter(s) - Medical Review(s) - Clinical Pharmacology Biopharmaceutics Review(s) - Administrative Document(s) - -...
author: Paul Stauffer
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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 enuresis
ESTROGENS/ CONJUGATED MEDROXYPRO-GESTERONE ACETATE 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
GOSERELIN...
author: Brenda Harmon
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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
Limit on Number of Embryos The licensee is not permitted by law to place more than three embryos in a woman...
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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...
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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...
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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...
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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,...
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