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,...
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
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
Estrogen replacement therapy (ERT) - [Medication] - Quest Diagnostics Patient Health Library Brand Name Chemical Name Estrace estradiol Transdermal (patch placed on the skin that releases estrogen continuously) Brand Name Chemical Name Alora, Climara, ClimaraPro, low-dose, Estraderm, Vivelle-Dot estradiol Vaginal ring (inserted high into the vagina; releases estrogen continuously for 3 months) Brand Name Chemical Name Femring estradiol Skin cream ...
Femring Drug Review Package FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New.@ CDER - Search - Drug Review Package Femring (estradiol acetate) vaginal ring Company:- Galen Limited Application No.:- 021367 Approval Date:-3/20/2003 Approval Letter(s) - Medical Review(s) - Chemistry Review(s) - Pharmacology Review(s) - Statistical Review(s) - Clinical Pharmacology...
http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf Barr Laboratories, Inc.Acetate tablets, a cardiovascular product, which is sold under the brand name Tambocor TM.Acetate, which we intend to market in the United States under the name CyPat, is a steroid that blocks the action of testosterone.
http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf page 15
Pages Additional Patent Challenges During fiscal 2003, we announced five additional patent challenges, including challenges for: Eli Lilly's Evista® product for the treatment and prevention of osteoporosis in postmenopausal women; Kos Pharmaceutical's Niaspan® 500 mg and 750 mg extended release tablets for cholesterol; Ferring's patent related to DDAVP® (Desmopressin ...
author: Lisa
Products: listing products site map privacy policy disclaimer - Browse Our Product Types - Search Our Products - Browse Our Categories Products: listing products Category NEW PRODUCTS [NEW] 357 "NEW PRODUCTS" found NEW PRODUCTS Name Isotope Qty Price "CELL FREE" AMINO ACID MIX (U-13C, 98%; U-D, 98%; U-15N, 98%) 0.5G $2,500.00 "CELL FREE" AMINO ACID MIX (20AA) (U-D, 98%) G Please Inquire "CELL FREE" AMINO ACID...
Products: listing products >> NEW PRODUCTS -- - Name Isotope Qty Price NEW PRODUCTS [ top ] "CELL FREE" AMINO ACID MIX (U-13C, 98%; U-D, 98%; U-15N, 98%) 0.5G $2,500.00 "CELL FREE" AMINO ACID MIX (20AA) (U-D, 98%) G Please Inquire "CELL FREE" AMINO ACID MIX (20AA) (U-D, 98%; U-15N, 98%) G Please Inquire 0.1% METHANOL-13C + 0.3 MG/ML GDCL3 IN 98.9% D2O + 1% H2O 1 5MM TUBE $110.00 0.1MG/ML GDCL3 +0.1 % DSS 20%...
IROA - Scientific Study Reference Search Pellets 2-Acetamidofluorene (2-AAF) 2-Acetylaminofluorene (AAF) 2-OHE1 3,3',5-Triiodo-L-Thyronine (T3) 4-Hydroxyandrostene-3,17-dione (4-OHA) 4-Hydroxyandrostenedione 5a-Androstan-3a + 17ss-diol 5a-Dihydrotestosterone (5a-DHT) 5a-Dihydrotestosterone (5a-DHT) 5a-Reductase Inhibitor (4MA) 5-Bromo-2'-Deoxyurdine (BrDU) 5a-Dihydrotestosterone (5a-DHT) 6-n-Propyl-2-Thiouracil (PTU...
Miscellaneous (PLEASE INQUIRE) 2-ACETAMIDOFLUORENE (2-AAF) A-102 A-21 SA-102 A-60 NA-102 A-90 9,10-DIMETHYL-1,2-BENZANTHRACENE D-117 A-21 SD-117 A-60 ND-117 A-90 ALLOXAN A-103 A-21 SA-103 A-60 NA-103 A-90 ALTHIAZIDE A-104 B-21 SA-104 B-60 NA-104 B-90 AMINOACETONITRILE A-105 B-21 SA-105 B-60 NA-105 B-90 AMINOPYRINE A-109 B-21 SA-109 B-60 NA-109 B-90 BACLOFEN B-110 A-21 SB-110 A-60 NB-110 A-90...
Pellets for Immuno 278J Progress in Cancer Research & Therapy, 35:430-435 1988 - - Testosterone, 5α -Dihydrotestosterone, Flutamide and Cyproterone Acetate Pellets for Tumor Growth and Regression in Immuno-Deficient Mice - It has been established that the growth and regression of androgen-dependent tumor tissue in mice is dependent upon three factors: 1.
Drug Approvals - D Desferal (deferoxamine mesylate, USP) Injection,- Novartis Pharmaceutical Company NDA 16-267/S-039 2/14/02 3/8/02 Desferal (deferoxamine mesylate, USP) Injection,- Novartis Pharmaceutical Company NDA 16-267/S-034 4/9/01 10/16/02 - - Desmopressin Acetate Injection,4 mcg/mL (packaged in 1 mL ampules), Rx Abbott Laboratories ANDA 75-220 8/28/00 10/31/00 - - Desmopressin Acetate ...
Drug Approvals - A NDA 9-048/S-037 3/26/03 4/15/03 4/1/03 (17-beta-estradiol transdermal), patch 3 sizes 13.5, 20, and 27cm2, with normal delivery of.05,.075 and 0.1mg per day for 7 days., Rx Trade name not established Wyeth-Ayerst NDA 21-048 9/20/99 9/24/99 9/24/99 - - 17-beta-estradiol transdermal Indication: Treatment of vulvar vaginal atrophy and vasomotor symptoms Abilify (aripiprazole...
Prescription and Over-the-Counter Drug Product List: 1/2004 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETYLCYSTEINE >A> INJECTABLE; INTRAVENOUS >A> ACETADOTE >A> + CUMBERLAND PHARMS 6GM /30ML(200MG/ML) N21539 001 JAN 23, 2004 JAN NEWA ALBUTEROL SULFATE TABLET, EXTENDED RELEASE; ORAL ALBUTEROL SULFATE >D> AB PLIVA EQ 4MG BASE N76130 002 SEP 26, 2002 JAN CRLD >A> + EQ 4MG BASE N76130 002 SEP 26, 2002 JAN CRLD >D> AB EQ 8MG BASE...
Drug Approvals - M NDA 16-979/S-051 8/27/02 8/30/02 Megestrol Acetate Oral Suspension, 40 mg/mL., Rx Roxane Laboratories, IncAcetate Oral Suspension, 40 mg/mL., Rx Copley Pharmaceutical ANDA 75-681 5/5/03 - - - Megestrol Acetate Oral Suspension, 40 mg/mL., Rx Par Pharmaceutical, Inc
Drug Approvals - N ANDA 40-455 3/3/03 Norethindrone Acetate Tablets USP, 5 mg, Rx Barr Laboratories, IncEstradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg, packaged in 28-day cycle regimens, Rx Tentatively Approved 1/6/2004 - Andrx Pharmaceuticals ANDA 76-335 1/6/04 Norgestrel and Ethinyl ...
1996 and Older - New Drug Application (NDA) 18891-S15 9/6/96 8/5/2003 Cefotan/cefotetan disodium injection [1.8 MB] Zeneca Pharmaceuticals 50694 7/30/1993 3/4/1999 Cerebyx Injection Parke Davis 020450/S1 12/26/1996 6/17/2003 Claritin Tablets Schering 19658/S005 2/15/94 5/25/01 Climara (estradiol transdermal system) 3M Pharmaceuticals 20375 - S5 05/17/1996 8/11/2003 Climara (estradiol transdermal system) 3M...
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...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 CASPOFUNGIN ACETATE MERCK RES 21-227 SE1 007 7-Mar-02 7-Jan-03 10.1 Provides for the use of Cancidas (caspofungin acetate) For Injection for the treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infectionsACETATE WYETH AYERST 20-527 SE2 017 15-Jun-00 12-Mar...
C:\Data\My Documents\drugs\estrogen\WHI labeling supps\femhrt\AP \ 21065 S-009.doc The structural formulas are as follows: OH CH 3 O H H C CH H H Ethinyl Estradiol Molecular Weight: 296.41 Molecular Formula: C20H24O2 Revised January 5, 2004 2 O CH 3 O H CCH 3 O H C CH H H Norethindrone Acetate Molecular Weight: 340.47 Molecular Formula: C22H28O3 CLINICAL PHARMACOLOGY Estrogens are largely responsible for the development and maintenance of the female...
author: Bronwyn Collier
C:\Data\My Documents\drugs\estrogen\WHI labeling supps\femhrt\AP \ 21065 S-009.doc page 2
author: Bronwyn Collier
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt IN LAFAYETTE, INDIANA" 4676 27-Sep-82 BASF AKTIENGESELLSCHAFT 13-CIS-RETINOIC ACID (ISOTRETINOIN) 4684 13-Oct-82 SCHERING AG "ESTRADIOL MANUFACTURED IN BERLIN, GERMANY." 4687 14-Oct-82 SUMIKA FINE CHEMICALS CO LTD DISOPYRAMIDE PHOSPHATE USP XX 4688 16-Oct-82 KONGO CHEMICAL CO LTD DEXCHLORPHENIRAMINE MALEATE 4690 13-Oct-82 SCHERING AG ESTRADIOL -3-BENZOATE 4691 19-Oct-82...
