http://www.fda.gov/cder/orange/appendix_a.txt 45, DIHYDROERGOTAMINE MESYLATE DACARBAZINE, DACARBAZINE DALGAN, DEZOCINE DALMANE, FLURAZEPAM HYDROCHLORIDE DANAZOL, DANAZOL DANOCRINE, DANAZOL DANTRIUM, DANTROLENE SODIUM DAPSONE, DAPSONE DARANIDE, DICHLORPHENAMIDE DARAPRIM, PYRIMETHAMINE DARBID, ISOPROPAMIDE IODIDE DARICON, OXYPHENCYCLIMINE HYDROCHLORIDE DARVOCET A500, ACETAMINOPHEN DARVOCET, ACETAMINOPHEN DARVOCET-N 100,...
1998 Warning Letters and Untitled Letters to Pharmaceutical Companies DDMAC 6/25 6/29 Maxipime (Cefepime HCl) for Injection Bristol-Myers Squibb DDMAC 6/29 8/3 Mircette (Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol) Tablets Organon DDMAC 6/1 6/9 Naprelan (Naproxen Sodium) Tablets Wyeth-Ayerst DDMAC 6/8 6/29 Nasacort (Triamcinolone Acetonide) Rhone-Poulenc Rorer DDMAC 6/25 6/29 Nasonex (mometasone furoate monohydrate) nasal...
http://www.int-med.uiowa.edu/Intranet/Residents/xToDelete/GMedCurricOld/Jan-Jun%2004/Contraception/UTD-Oral.pdf Pills containing less than 50 ~g of ethinyl estradiol have been referred to as "low- dose" pills.ethinyl estradiol with increasing doses of desogestrel (100, 125, and 150 ug days 1 to 7, 8 to 14, and 15 to 21, respectively).desogestrel, and gestodene (showtab...
author: floerchingerd [ M68498 ]
FDA Drug Approvals List- March 1998 PEDIATRIC Dosage Form: INJECTABLE Applicant: ASTRA USA INC Active Ingredient(s): ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E OTC/RX Status: RX Application #: 050672 Labeling Supplement #: 012 To Original New Drug...
DDPA April 1995 74-481 CAPTOPRIL INVAMED CAPTOPRIL 28-APR-95 (TABLET) DAYTON, NJ 12.5MG 08810 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-646 PERGONAL SERONO MENOTROPINS-- 05-APR-95 (INJECTABLE) BRAINTREE, MA FOLLICLE 02184 STIMULATING HORMONE 75IU/AMP LUTEINIZING HORMONE 75IU/AMP (LABELING REVISION -- ADVERSE REACTIONS) 17-646 PERGONAL...
DDPA February 1995 74-047 ZIDOVUDINE BARR ZIDOVUDINE 24-FEB-95 (C APSULE) POMONA, NY 100MG 10970 (ANTIVIRAL) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-970 NOLVADEX ZENECA PHARMS TAMOXIFEN CITRATE 01-FEB-95 (TABLET) WILMINGTON, DE EQ 10MG BASE 19850 (LABELING REVISION -- WARNINGS) 20-055 GLYBURIDE (MICRONIZED) HOECHST ROUSSEL GLYBURIDE 01-FEB-95 (TABLET) SOMERVILLE, NJ 1.5MG 08876 3MG (LABELING...
FDA DRUG AND DEVICE PRODUCT APPROVALS 74-776 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE 26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.5% 33637 (BETA ADRENERGIC BLOCKER) 74-778 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE 26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.25% 33637 (BETA ADRENERGIC BLOCKER) 74-465 TIMOLOL MALEATE ADV REMEDIES TIMOLOL MALEATE 30-JUL-96 (SOLUTION/DROPS) SOMERSET, NJ 0.25% 08873 (BETA ADRENERGIC...
July Drug Approvals Drug Approvals for July 1996 Definitions and Notes Original New Drug Application Original Application #: 020538 Approval Date: 31-JUL-96 Trade Name: ESTRADIOL Chemical Type: Already marketed drug product but a new manufacturer Therapeutic Potential: Standard review drug Dosage Form: FILM, EXTENDED RELEASE Applicant: MENOREST MANFACTURING INC Active Ingredient(s): ESTRADIOL ...
Combination hormonal birth control methods (pills, patch, or ring) - [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 Combination hormonal birth control methods (pills, patch, or ring) - [Medication] - Quest Diagnostics Patient Health Library Combination hormonal birth control methods (pills, patch, or ring) - [Medication] - Quest Diagnostics Patient Health Library Hormones...
LF-53826 DESCRIPTION Mircette ® (desogestrel/ ethinyl estradiol and ethinyl estradiol) Tablets provide an oral contraceptive regimen of 21 white tablets each containing 0.15 mg desogestrel (13- ethyl- 11- methylene- 18,19- dinor- 17 alpha- pregn- 4- en- 20- yn- 17- ol), 0.02 mg ethinyl estradiol (19- nor- 17 alpha- pregna- 1,3,5 (10)- trien...
author: Eithne Kearns
LF-53826 page 2
author: Eithne Kearns
LF-53826 page 1
author: Eithne Kearns
http://www.barrlabs.com/overview/annual/BRL_AR2002.pdf page 49
Pages page 53
author: Lisa
THE MERCK MANUAL, Sec. 18, Ch. 246, Family Planning This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 18.ethinyl estradiol, and women taking formulations with 50 µg of estrogen should usually be switched to low-dose formulations.
Drug Approvals - D NDA 21-333 9/16/02 9/20/02 9/17/02 - Desogestrel & Ethinyl Estradiol Tablets, Rx Barr Laboratories ANDA 76-455 2/24/04 4/15/03 Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively, Rx Tentatively Approved Duramed Pharmaceuticals ANDA 75-863 11/29/01 4/15/03 Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03,...
What's new at CDER by Date New and Generic Drug Approvals Desogestrel & Ethinyl Estradiol Tablets, Barr Laboratories Methamphetamine Hydrochloride Tablets, Able Laboratories Mexitil (mexiletine hydrochloride) Capsules, Boehringer Ingelheim Pediatric Drug Development: Pediatric Exclusivity Granted (updated) Federal Register Notice (69 FR 7243)- List of Drugs for Which Pediatric Studies Are...
author: Paul Stauffer
C:\Data\My Documents\aNDA\Labeling\21090 Cyclessa\003 AP ltr .doc page 1
author: Dale Cutright
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...
THE MERCK MANUAL, Sec. 18, Ch. 246, Family Planning This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 18ethinyl estradiol, and women taking formulations with 50 µg of estrogen should usually be switched to low-dose formulations
Maximum Recommended Therapeutic Dose (MRTD) Database Maximum Recommended Therapeutic Dose (MRTD) Database (1,235 pharmaceuticals) A -- B- - C -- D -- E -- F-G -- H-K -- L -- M -- N -- O -- P -- Q-R -- S -- T -- U-Z MRTD--- (mg/kg--- bw/day) -- Generic Chemical Name Chemical Structure (SMILES Code) 3.00000-- Acemetacin C1=C(OC)C=C3C(=C1)N(C(=O)C2=CC=C(Cl)C=C2)C(C)=C3CC(=O)OCC(O)=O 0.20000-- Acenocoumarol C1=CC=C3C(=C1)OC(=O)C(C(CC(C)=O...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 4Q2003 TYPE2ACTIVETEXT DMF # SUBMIT DATE HOLDER SUBJECT 131 01-Jan-40 CENTRAL SOYA SOYBEAN STEROL PRODUCTS 183 29-Feb-52 INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 191 24-Jan-56 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) 240 11-Jan-57 PHARMACIA & UPJOHN 19-NOR-ETHINYLTESTOSTERONE 281 21-Nov-57 UNIMED PHARMACEUTICALS INC 2 HYDROXY...
http://www.int-med.uiowa.edu/Intranet/Residents/xToDelete/GMedCurricOld/Jan-Jun%2004/Contraception/UTD-Oral.pdf page 4
author: floerchingerd [ M68498 ]
lan;02dec00 Since the 1995 scare, 7 scientists amd clinicians have endeavoured to explain and put in context the observed differential risk of venous thromboembolism (VTE) between secondgeneration combined OCs containing levonorgestrel and third- generation combined OCs containing desogestrel or gestodene.desogestrel 75 g, which as an ovulationinhibiting progestagen...
author: bos
lan;02dec00 page 6
author: bos
