|
|
|
|
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.
Ovulation usually occurs about 14 days before onset of the next menses.
New users should be given low-dose formulations with 20 to 35 µg of 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 18
Ovulation usually occurs about 14 days before onset of the next menses
New users should be given low-dose formulations with 20 to 35 µg of ethinyl estradiol, and women taking formulations with 50 µg of estrogen should usually be switched to low-dose formulations
Other...
|
|
|
http://www.fda.gov/cder/orange/appendix_a.txt
IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, BACITRACIN ZINC NEOSPORIN, GRAMICIDIN NEOSPORIN, NEOMYCIN SULFATE (OTC) NEOTHYLLINE, DYPHYLLINE NEOTRIZINE, TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE; SULFAMETHAZINE) NEPHRAMINE 5.4%, AMINO ACIDS NEPHROFLOW, IODOHIPPURATE SODIUM, I-123 NEPTAZANE, METHAZOLAMIDE NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE...
|
|
|
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.
Cyclessa is a triphasic preparation containing 25 ug of ethinyl estradiol with increasing doses of desogestrel (100, 125, and 150 ug days 1 to 7, 8 to 14, and 15 to 21, respectively).
They include norgestimate, 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.
An example is 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...
|
|
|
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 0.003mg ethinyl estradiol...
|
|
|
Ortho-McNeil: Our Products
Prescribing Information - ALL-FLEX ® Arcing Spring Diaphragm Contraceptive Molded, dry natural rubber vaginal diaphragm containing a distortion-free, dual spring-within-a-spring AXERT ® Tablets (almotriptan malate) Migraine Oral medication for acute treatment of migraine with or without aura in adults; available in 6.25mg and 12.5mg, 6-tablet blister - DITROPAN ® ...
|
|
|
Reference Listed Drug Labeling Approved in October 2000
Oct 2 MOTRIN IB ibuprofen tablets 19-012/S-024 ANECTINE succinylcholine chloride injection 08-453/S-019 Oct 3 TRACRIUM atracurium besylate injection 18-831/S-022 CHLOROPTIC chloramphenicol ophthalmic solution 50-091/S-008 MIRCETTE desogestrel and ethinyl estradiol tablets 20-713/S-007 ARTHROTEC diclofenac sodium/misoprostol tablets 20-607/S-005 Oct 4 SANDIMMUNE...
author: John Grace
|
|
|
Guidance for Industry Combined Oral Contraceptives -Labeling for Healthcare Providers and Patients
The following section contains information on drug interactions with ethinyl estradiol-containing products that have been reported in the public literature
The metabolism of ethinyl estradiol is increased by rifampin and anticonvulsants such as phenobarbitol, phenytoin, and carbamazepine
Coadministration of troglitazone and certain ethinyl ...
author: Derr
|
|
|
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
|
