http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
FDA Drug Approvals List April 2002 - Drug Approvals for April 2002 Definitions and Notes Original New Drug Applications Original Application #: 021310 Approval Date: 05-APR-02 Trade Name: ALORA Chemical Type: 3 Therapeutic Potential: S Dosage Form: PATCH, CONTROLLED RELEASE Applicant: WATSON LABORATORIES INC Active Ingredient(s): ESTRADIOL OTC/RX Status: RX Indication(s): For the prevention of postmenopausal...
Prescription and OTC Drug Product List 4/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL ACETAMINOPHEN, BUTALBITAL, CAFFEINE, AND CODEINE PHOSPHATE -A- AB VINTAGE PHARMS 325MG;50MG;40MG;30MG N75929 001 APR 22, 2002 APR NEWA ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE;...
AR 2007 Lo Res.pdf Barr now operates in over 30 countries across the world.ethinyl estradiol tablets 0.15 mg/ 0.03 mg and ethinyl estradiol tablets 0.01 mg) extended- cycle...
Pages Barr Laboratories, Inc.ethinyl estradiol for 84 consecutive days, followed by a sevenday interval during which placebo pills are taken...
author: Lisa
Drug Approvals - K Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Kaletra (lopinavir) oral solution, 80mg lopinavir/20mg ritonavirKariva (Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol) Tablets, Rx Barr...
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
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...
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 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 ]
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
Ortho-McNeil: Our Products - ORTHO-CEPT ® Tablets (desogestrel/ethinyl estradiol) Contraceptive Combination oral contraceptive product containing 0.15mg desogestrel and 0.03mg ethinyl estradiol - ORTHO-CYCLEN ® Tablets (norgestimate/ethinyl estradiol) Contraceptive Combination contraceptive product containing 0.250mg norgestimate and 0.035mg ethinyl estradiol ...
