http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
FDA Drug Approvals List April 2000 Approvable Original New Drug Applications Original Abbreviated New Drug Applications Original Abbreviated Application # 074657 Approval Date: 28-APR-00 Trade Name: TERAZOSIN HCL Dosage Form: TABLET Applicant: INVAMED INC Active Ingredient(s): TERAZOSIN HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application# 065041 Approval Date: 28-APR-00 Trade Name: DOXYCYCLINE...
EFFICACY SUPPLEMENTS APPROVED IN CY 2000 EFFICACY SUPPLEMENTS APPROVED IN CY 2000 GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION IBUPROFEN WHITEHALL ROBINS 20-812 15-Jun-98 12-Jan-00 SE5 003 N 18.9 Provides for the use of Infants' Advil (ibuprofen oral suspension) Concentrated Oral Drops, 50 mg/1.25 mL for ages 6 months...
http://www.fda.gov/cder/foi/label/2000/21103lbl.pdf Activella ™ PHYSICIAN PACKAGE INSERT 4/ 10/ 2000 Page 5 of 29 4/ 10/ 2000 TABLE 1 PHARMACOKINETIC PARAMETERS AFTER A SINGLE DOSE OF ACTIVELLA ™ IN HEALTHY POSTMENOPAUSAL WOMEN Activellaae (n= 25) Mean C ± SD Estradiol a (E2) AUC (0- 72h) (pg/ mL* h) 1053 ± 310 C max (pg/ mL) 34.6 ± 10.8 t max (h) 6.8 ± 2.9 t 1/ 2 (h) d 13.2 ± 4.7...
http://www.fda.gov/cder/foi/label/2000/21103lbl.pdf page 8
http://www.fda.gov/cder/foi/label/2000/21103lbl.pdf page 2
Hormone replacement therapy (HRT) - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Hormone replacement therapy (HRT) - [Medication] - Quest Diagnostics Patient Health Library Hormone replacement therapy (HRT) - [Medication] - Quest Diagnostics Patient Health Library Hormones, Sexual and reproductive organs, Sexual health, Women’s...
http://www.fda.gov/cder/foi/label/2000/21103lbl.pdf page 7
http://www.fda.gov/cder/foi/label/2000/21103lbl.pdf page 5
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...
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
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...
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 ...
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...
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...
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 NAPROXEN 2033 22-Dec-72 SCHERING AG NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) 2035 28-Dec-72 PHARMACIA AND UPJOHN INC TRIAMCINOLONE 2048 08-Feb-73 PFANSTIEHL LABORATORIES INC CREATINE 2063 15-Jan-73 PALL CORP FILTER CARTRIDGE 2098 27-Apr-73 PHARMACIA AND UPJOHN SPA ADRIAMYCIN HCL BULK 2115 14-Jun-73 LUNDBECK PHARMACEUTICALS ITALY SPA HYDROCHLOROTHIAZIDE USP...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls NAPROXEN SCHERING AG NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) PHARMACIA AND UPJOHN INC TRIAMCINOLONE PFANSTIEHL LABORATORIES INC CREATINE PALL CORP FILTER CARTRIDGE PHARMACIA AND UPJOHN SPA ADRIAMYCIN HCL BULK LUNDBECK PHARMACEUTICALS ITALY SPA HYDROCHLOROTHIAZIDE USP SOLMAG S.P.A PHENDIMETRAZINE TARTRATE SIFAVITOR SPA TRICHLORMETHIAZIDE NF XIII LILLY RES LABS...
21-276_Estrostep.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Estrostep Fe (Norethindrone Acetate, 1mg & Ethinyl Estradiol, 35mcg) Tablets Company:--Parke-Davis Pharmaceutical Research Application No.:--21-276 Approval Date:-7/13/2001 - Approval Letter(s) - Printed Labeling - Medical Review(s) Part 1 Part 2 Part 3 - Chemistry...
author: Paul Stauffer
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004 - TABLET; DELAYED-RELEASE, ORAL Approved 4/18/2000- ETHINYL ESTRADIOL 0.035 MG NORETHINDRONE 0.4 MG - 99P-1150/CP1 KIRKLAND & ELLIS - TABLET; CHEWABLE Approved 4/14/2000- CLOZAPINE 12.5 MG - 99P-1267/CP1 LACHMAN CONSULTANT SERVICES - TABLET;ORAL Approved 2/17/2000- CLOZAPI NE 200 MG - 99P-1268/CP1 LACHMAN CONSULTANT SERVICES - TABLET; ORAL Approved 2/17/2000-...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004 - INJECTION Approved 8/13/2003- ESTROPIPATE 1.2 mg - 02P-0141/CP1 WOMEN FIRST HEALTHCARE - TABLETS Approved 9/24/2002- ETHINYL ESTRADIOL 0.035 MG NORETHINDRONE 0.4 MG - 99P-1150/CP1 KIRKLAND & ELLIS - TABLET; CHEWABLE Approved 4/14/2000- FAMOTIDINE 10MG - 00P-1422/CP1 YAMANOUCHI PHARMA TECHNOLOGIES - TABLET; ORALLY DISINTEGRATING Approved 4/17/2001- FENOFIBRATE 107 mg -...
Prescription and Over-the-Counter Drug Product List: 11/2003 ACTHAR GEL >D> BC + QUESTCOR PHARMS 80 UNITS/ML N08372 008 NOV CTEC >A> + 80 UNITS/ML N08372 008 NOV CTEC CYTARABINE INJECTABLE; INJECTION >D> CYTARABINE >D> AP + GENSIA SICOR PHARMS 100MG/VIAL N16793 001 NOV DISC >D> AP + 500MG/VIAL N16793 002 NOV DISC >D> AP + 1GM/VIAL N16793 003 DEC 21, 1987 NOV DISC >D> AP + 2GM/VIAL N16793 004 DEC 21, 1987 NOV DISC >A> @ SICOR PHARMS 100MG/VIAL...
ANDA Approvals - September 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - September 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 76-220 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG - RANBAXY LABORATORIES LIMITED 9/2/2003- 2 76-093 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG - PAR PHARMACEUTICAL, INC
