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http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W/ CODEINE, CODEINE...
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ANDA Approvals May 2002
5/23/02 13 75-866 LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.15 MG/0.03 MG; PACKAGED IN 21-DAY (PORTIA-21) AND 28-DAY (PORTIA-28) CYCLES BARR LABORATORIES, INC
5/28/02 19 75-834 MILRINONE LACTATE IN 5% DEXTROSE INJECTION 0.2 MG (BASE)/ML, PACKAGED IN 100 ML AND 200 ML SINGLE-DOSE PLASTIC CONTAINERS FOR INTRAVENOUS INFUSION BAXTER...
author: OGD
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FDA Drug Approvals List May 2002
- Drug Approvals for May 2002 Definitions and Notes Original New Drug Applications Original Abbreviated Antibiotic Application # 065082 Approval Date: 31-MAY-02 Trade Name: CEFPODOXIME PROXETIL Dosage Form: GRANULE, FOR RECONSTITUTION Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): CEFPODOXIME PROXETIL OTC/RX Status: RX Original Application #: 021292 Approval Date: 31-MAY...
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Prescription and OTC Drug Product List 5/2002
2 -D- + ROBINS AH 325MG;15MG N84444 001 MAY DISC -A- @ 325MG;15MG N84444 001 MAY DISC SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -D- AA ALPHARMA 120MG/5ML;12MG/5ML N85861 001 MAY CRLD -A- AA + 120MG/5ML;12MG/5ML N85861 001 MAY CRLD TYLENOL W/ CODEINE -D- AA + JOHNSON RW 120MG/5ML;12MG/5ML N85057 001 MAY DISC -A- @ 120MG/5ML;12MG/5ML N85057 001 MAY DISC TABLET; ORAL...
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AR 2007 Lo Res.pdf
Barr now operates in over 30 countries across the world.
FINANCIALS On September 21, 2006, Barr' s Board of Directors approved a resolution to change the fiscal year- end from June 30 to December 31 in order to align our fiscal year- end with other companies within our industry.
Congress.
INTERNATIONAL PRODUCT MARKETING The European generic pharmaceutical market varies...
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233040 Seasonale
The risks associated with taking oral contraceptives increase significantly if you: Rx only (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg (levonorgestrel / ethinyl estradiol...
author: Mary
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233040 Seasonale page 2
author: Mary
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233040 Seasonale page 1
author: Mary
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Pages
Barr Laboratories, Inc.
Under the SEASONALE extended regimen, women take active contraceptive tablets of 0.15 mg of levonorgestrel/ 0.03 mg of ethinyl estradiol for 84 consecutive days, followed by a sevenday interval during which placebo pills are taken to induce a withdrawal bleeding period.
In contrast, traditional oral contraceptives follow a 21- day...
author: Lisa
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Pages page 6
author: Lisa
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Wyeth: Products: Full Pharmaceutical Product List (A-Z)
Select either "Prescribing Information" or "Product Information" to find out more about a specific product.
A-C D-F G-K L-N O-Q R-T U-Z Alesse ® (0.1 mg levonorgestrel/ 0.02 mg ethinyl estradiol tablets) ---- Please see Important Warnings and Prescribing Information ---- Patient Information ALTACE ® (ramipril) Capsules - - - Product Information ---- Please see Important...
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Wyeth: Products: Full Pharmaceutical Product List (A-Z)
Triphasil® Tablets (levonorgestrel, and ethinyl estradiol tablets/triphasic regimen) Prescribing Information Prescribing Information for this product may differ according to regimen.
Please select the appropriate Prescribing Information from the list below.
This icon links to Prescribing Information.
These files require Adobe Acrobat Reader.
Click...
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Wyeth: Products: Human Health
as of December 31, 2002 ---- Prescribing Information Robitussin ® AC (guaifenesin/codeine phosphate) Syrup - - - Product Information Robitussin ® Brands - - - Product Information Robitussin ® -DAC (guaifenesin/codeine phosphate/pseudoephedrine HCl) Syrup - - - Product Information Synvisc ® (hylan G-F 20) Please note: The sales and marketing rights to this product were...
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Wyeth: Products: All Products (A-Z)
as of December 31, 2002 ---- Prescribing Information Robitussin ® AC (guaifenesin/codeine phosphate) Syrup - - - Product Information Robitussin ® Brands - - - Product Information Robitussin ® -DAC (guaifenesin/codeine phosphate/pseudoephedrine HCl) Syrup - - - Product Information Synvisc ® (hylan G-F 20) Please note: The sales and marketing rights to this product were...
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Emergency contraception - [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 Emergency contraception - [Medication] - Quest Diagnostics Patient Health Library Emergency contraception - [Medication] - Quest Diagnostics Patient Health Library Hormones, Sexual and reproductive organs, Sexual health, Women’s health, Aviane, BCP,...
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http://www.paladin-labs.com/pdf_files/2005_10_26.pdf
NEWS RELEASE PALADIN AND DURAMED SIGN SEASONALE PRODUCT CANADIAN LICENSE AND DISTRIBUTION AGREEMENT First Filing for Approval of SEASONALE ® Extended- Cycle Oral Contraceptive Outside of the United States Montreal, Canada, October 26, 2005 – Paladin Labs Inc.
On September 30, 2005, Paladin filed on behalf of Duramed the New Drug Submission (NDS) for Seasonale ® with...
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http://www.paladin-labs.com/pdf_files/2005_10_26.pdf page 1
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http://www.wyeth.com/news/pdf/2005_3Q.pdf
IMMEDIATE RELEASE Media Contact: Investor Contact: Douglas Petkus Justin Victoria (973) 660- 5218 (973) 660- 5340 Wyeth Reports Earnings Results for the 2005 Third Quarter and First Nine Months O Worldwide Net Revenue for the 2005 Third Quarter and First Nine Months Increased 5% and 10% to $4.7 Billion and $14.0 Billion, Respectively O Enbrel ® , Prevnar ® Performance...
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BioPortfolio Limited
focus of concern shifts towards the UK 70 Market analysis: leading and new product sales to 2008 71 Wyeth 73 Premarin family (conjugated estrogens) 73 Novartis 79 Schering AG 79 Climara and Climara Pro (estradiol) 80 Avaden (estradiol/gestodene) 81 Solvay 82 Estratest (esterified estrogens/methyltestosterone) 82 Organon 83 Novo Nordisk 84 Outlook for the HRT market 85 Unmet...
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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 ...
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Drug Approvals - M
ANDA 40-396 2/27/01 3/5/01 - - Micro-K and Micro-K 10 Extencaps Extended-Release Capsules,- KV Pharmaceutical Company NDA 18-238/S-031 8/20/03 8/25/03 Microgestin Fe 1/20 Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1.0 mg/0.02 mg, Ferrous Fumarate Tablets, 75mg),Rx Watson Laboratories, Inc
ANDA 75-647 2/5/01 3/5/01 - - Microgestin Fe 1.5/30...
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Drug Approvals - N
NDA 13-416/S21 11/25/02 12/6/02 11/26/02 Norgestimate and Ethinyl Estradiol 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 Estradiol SCS P harmaceuticals ANDA 075288 07/28/1999 12/23/03 Noritate ...
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Prescription and Over-the-Counter Drug Product List: 12/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA...
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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...
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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003 TYPE2ACTIVEEXCEL DMF # SUBMIT DATE HOLDER SUBJECT CENTRAL SOYA SOYBEAN STEROL PRODUCTS INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE ...
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