http://www.fda.gov/cder/orange/appendix_a.txt 12, CHLORPHENIRAMINE MALEATE (OTC) CODOXY, ASPIRIN CODRIX, ACETAMINOPHEN COGENTIN, BENZTROPINE MESYLATE COGNEX, TACRINE HYDROCHLORIDE COL-PROBENECID, COLCHICINE COLAZAL, BALSALAZIDE DISODIUM COLBENEMID, COLCHICINE COLD CAPSULE IV, CHLORPHENIRAMINE MALEATE (OTC) COLD CAPSULE V, CHLORPHENIRAMINE MALEATE (OTC) COLESTID, COLESTIPOL HYDROCHLORIDE COLGATE TOTAL, SODIUM FLUORIDE (OTC)...
Prescription and OTC Drug Product List 8/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 8: August 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MODURETIC 5-50 - ADD - AB MALLINCKRODT...
Prescription and OTC Drug Product List 3/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 3: January-March 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ATORVASTATIN CALCIUM CAPSULE; ORAL TABLET; ORAL - ADD - BUTALBITAL; ACETAMINOPHEN; AND CAFFEINE WITH CODEINE LIPITOR - ADD - PHOSPHATE ...
FDA Drug Approvals List- August 1998 Specifically, the new indication is for the use of lamotrigine for adjunctive treatment of Lennox-Gastaut syndrome in pediatric and adult patients Original Application #: 020870 Approval Date: 07-AUG-98 Trade Name: COMBIPATCH Chemical Type: 3 Therapeutic Potential: S Dosage Form: FILM, CONTROLLED RELEASE Applicant: RHONE POULENC RORER PHARMACEUTICALS INC Active Ingredient(s): ...
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.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
Prescription and Over-the-Counter Drug Product List: 9/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> + MIKART 325MG/15ML;7.5MG/15ML N40482 001 SEP 25, 2003 SEP NEWA ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL >A> OXYCODONE AND ACETAMINOPHEN >A> AA WATSON LABS 325MG;7.5MG N40535 001 SEP 05, 2003 SEP NEWA >A> AA 325MG;10MG...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 8/2003 4 >D> AA + ORTHO MCNEIL PHARM 300MG;60MG N85055 004 AUG DISC >A> @ 300MG;60MG N85055 004 AUG DISC ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA + MALLINCKRODT 500MG/15ML;10MG/15ML N40508 001 AUG 29, 2003 AUG NEWA >D> MIKART 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG CTEC >A> AA 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG...
author: AUTHOR
First-Time Generics - May 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - May 2003 - Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 MOEXIPRIL HYDROCHLORIDE TABLETS 7.5 MG AND 15 MG TEVA PHARMACEUTICALS USA UNIVASC TABLETS 5/8/2003- 2 BETAMETHASONE DIPROPIONATE GEL 0.05% (BASE) ALTANA INC
author: OGD
ANDA Approvals May 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - May 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 75-681 MEGESTROL ACETATE ORAL SUSPENSION, USP 40 MG/ML COPLEY PHARMACEUTICAL, INC
author: OGD
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AP + WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC >A> @ 5,000 UNITS/VIAL N17055 001 JUN DISC >D> AP + 10,000 UNITS/VIAL N17055 002 JUN DISC >A> @ 10,000 UNITS/VIAL N17055 002 JUN DISC GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE >D> AB WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >A> AB + EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >D> WYTENSIN ...
author: AUTHOR
