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...
FDA Drug Approvals List June 2002 - Drug Approvals for June 2002 Definitions and Notes Original New Drug Applications Original Application # 021316 Approval Date: 26-JUN-02 Trade Name: ALTOCOR Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: AURA LABORATORIES INC Active Ingredient(s): LOVASTATIN OTC/RX Status: RX INDICATION OF USE: For lowering total cholesterol and LDL-C to target levels as...
FDA Drug Approvals List- February 1999 Applicant: CONNETICS CORP Active Ingredient(s): BETAMETHASONE VALERATE OTC/RX Status: RX Indication(s):For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp Original Application #: 020969 Approval Date: 25-FEB-99 Trade Name: UVADEX Chemical Type: 3 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: THERAKOS INC...
03-14-02 - Baxter Announces Agreements to Expand Renal Product Portfolio Conditions Therapies Products Services About Baxter Baxter Worldwide > United States Training and Education Sustainability Contact Us - << Back to News Releases 2005 Archives 2004 Archives 2003 Archives 2002 Archives 2001 Archives News Release Home > About Baxter > News Room > News Releases BAXTER ANNOUNCES AGREEMENTS TO EXPAND RENAL PRODUCT PORTFOLIO Licensing Agreement with...
03-14-02 - 2002 Baxter Growth Conference Conditions Therapies Products Services About Baxter Baxter Worldwide > United States Training and Education Sustainability Contact Us - << Back to News Releases 2005 Archives 2004 Archives 2003 Archives 2002 Archives 2001 Archives News Release Home > About Baxter > News Room > News Releases BAXTER HIGHLIGHTS GROWTH INITIATIVES AT ANNUAL INVESTOR CONFERENCE Baxter Plans for Further...
ADVANCED MAGNETICS 2003 10-K page 10
author: Merrill Corporation
subject: ADVANCED MAGNETICS 2003 10-K
20955_Ferrlecit.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Ferrlecit (sodium ferric gluconate complex in Sucrose injectin) Company:- R & D Laboratories, Inc
author: Paul Stauffer
Report to the Nation: Drug Review Sodium ferric gluconate (Ferrlecit) treats iron deficiencyin end-stage renal disease for patients in hemodialysis who are receiving erythropoietin therapy
author: OLIVERN
LIST OF APPROVED DRUGS FOR WHICH ADDITIONAL PEDIATRIC INFORMATION DOCKET NOcomplex absence seizures & multiple seizure typescomplex partial seizures...
C:\My Documents\Supplements\20955101.4 NDA 20- 955/ S- 003 Page 3 Ferrlecit ® DESCRIPTION Ferrlecit ® (sodium ferric gluconate complex in sucrose injection) is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000 – 440, 000 daltons
author: Brian Strongin
C:\My Documents\Supplements\20955101.4 page 1
author: Brian Strongin
C:\Data\My Documents\Supplements\20955502.0.doc page 1
author: Brian Strongin
C:\My Documents\Supplements\20955101.4 page 1
author: Brian Strongin
Ferrlecit Consumer Information Ferrlecit ® Brand Name: Ferrlecit ® Active Ingredient: - sodium ferric gluconate complex in sucrose injection Strength(s): 12.5mg/ml Dosage Form(s): - intravenous injection Company Name: -- R & D Laboratories Availability: ------- Prescription only *Date Approved by FDA: - February 18, 1999 *Approval by FDA does not mean that a new drug will be...
CDER 1999 Report to the Nation New drug statistics: 83 new drugs 35 new molecular entities 28 priority approvals Median total approval time: 12.0 months Median FDA review time: 11.8 months Priority new drug approvals: Alitretinoin Amprenavir (2 dosage forms) Aspirin/ extended releasedipyridamole Bexarotene Busulfan Caffeine citrate Cytarabine liposome Dalfopristin/ quinupristin Epirubicin hydrochloride Ganirelix...
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
H: 955LBL.PDF February 18, 1999 NDA 20- 955 Ferrlecit Page 1 DESCRIPTION Ferrlecit ® (sodium ferric gluconate complex in sucrose injection) is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 350,000 + 23,000 daltonsFerrlecit ® for intravenous injection...
author: Unknown
H: 955LBL.PDF page 1
author: Unknown
H: 955LTR.PDF Makoff: Please refer to your new drug application (NDA) dated December 30, 1997, received December 30, 1997, submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Ferrlecit ® (sodium ferric gluconate complex in sucrose injection)Ferrlecit ® (sodium ferric gluconate ...
author: Unknown
H: 955LTR.PDF page 1
author: Unknown
NMEs Approved in CY 1999 NMEs Approved in Calendar Year 1999 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date - - - - - - - 20-863 Cilostazol Pletal Tablet Otsuka Pharm 1S 01-15-1999 20-886 Alitretinoin Panretin Topical Gel Ligand Pharm 1-PV 02-02-1999 20-955 Sodium Ferric Gluconate Complex Ferrlicit Injectable R&D Labs 1P 02-18-1999 21-007...
author: Elaine Abraham
OTC Drug Review Ingredient Status 12 INGREDIENT NAME ADDITIONS INGREDIENT NAME ADDITIONS TO THE AUGUST 1985 AND NOVEMBER 1986 EDITIONS: Dexbrompheniramine Maleate Dexchlorpheniramine Maleate Ipecac Tincture Jojoba Oil Nucleic Acids Polycarbophil, Calcium INGREDIENT NAME ADDITIONS TO THE AUGUST 1985 AND NOVEMBER 1986 EDITIONS (Cont'd): Polysorbate 20 Polysorbate 60 Sulfanilamide Sulfur (Paraffinic Hydrocarbons)...
author: Paul Stauffer
21136-1-DZ.1-454101-PrepressPdfNoBL.pdf page 11
author: Asura
Advanced Magnetics page 11
author: Merrill Corporation
subject: 10-K text
CDER 1999 Report to the Nation page 13
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
Efficacy Supplements Approved in Calendar Year 2001 (SE1-SE7 AND SE8S) -------------------- Top of Page -------- Last Updated on 1/28/02 ---- --- By CDER.USER EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2001 (SE8)* Top of Page GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) ADENOSINE FUJISAWA HLTHCARE 20-059 11-Aug-99 31-Aug-01 SE8 007 N 24.7 ATORVASTATIN CALCIUM PFIZER...
author: Darlene Norris
