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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...
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http://www.fda.gov/cder/orange/appendix_a.txt
400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE EC-NAPROSYN, NAPROXEN ECONAZOLE NITRATE, ECONAZOLE NITRATE ECONOCHLOR, CHLORAMPHENICOL ECONOPRED PLUS, PREDNISOLONE ACETATE ECONOPRED, PREDNISOLONE ACETATE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID EDETATE DISODIUM, EDETATE DISODIUM EDEX, ALPROSTADIL EDROPHONIUM CHLORIDE PRESERVATIVE FREE,...
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C:\Data\My Documents\drugs\estrogen\WHI labeling supps\femhrt\AP \ 21065 S-009.doc
Norethindrone acetate and ethinyl estradiol (EE) are rapidly absorbed from femhrt 1/ 5 tablets, with maximum plasma concentrations of norethindrone and ethinyl estradiol generally occurring 1 to 2 hours postdose
Mean (SD) Single- Dose (Day 1) and Steady- State (Day 87) Pharmacokinetic Parameters a Following Administration of 1 mg NA/ 10 mcg EE...
author: Bronwyn Collier
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C:\Data\My Documents\drugs\estrogen\WHI labeling supps\femhrt\AP \ 21065 S-009.doc page 2
author: Bronwyn Collier
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Prescription and Over-the-Counter Drug Product List: 5/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
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21065_Femhrt.htm
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Femhrt (Norethindrone Acetate & Ethinyl Estradiol) Tablets- Company:- Parke-Davis Pharmaceutical Research Application No.:- 21-065 Approval Date:-10/15/1999 - Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Chemistry Review(s) ...
author: Paul Stauffer
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Reference Listed Drug Labeling Approved in April 2000
Tradename Active Ingredient(s) / Dosage Form NDA/Sup# Firm April AMICAR Aminocaproic acid INJ 15-229 030 Immunex 3 AMICAR Aminocaproic acid TAB 15-197 034 Immunex 3 LO/OVRAL Norgestrel/ethinyl estradiol TAB 17-612 031 Wyeth Ayerst 3 NORDETTE-21 Levonorgestrel/ethinyl estradiol TAB 18-668 030 Wyeth Ayerst 3 PREVEN Levonorgestrel/ ethinyl estradiol TAB 20-946...
author: GraceJ
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FDA Drug Approvals List April 2000
Approvable Original New Drug Applications Original Abbreviated New Drug Applications Original Abbreviated Application # 074657 Approval Date: 28-APR-00 Trade Name: TERAZOSIN HCL Dosage Form: TABLET Applicant: INVAMED INC Active Ingredient(s): TERAZOSIN HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application# 065041 Approval Date: 28-APR-00 Trade Name: DOXYCYCLINE...
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FDA Drug Approvals List July 2000
- Drug Approvals for July 2000 Definitions and Notes Original New Drug Applications Original Application #: 050779 Approval Date: 27-JUL-00 Trade Name: CEFAZOLIN AND DEXTROSE Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: B BRAUN MEDICAL INC Active Ingredient(s): CEFAZOLIN SODIUM OTC/RX Status: RX Indication(s): For the treatment of respiratory tract...
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http://www.fda.gov/cder/ogd/rld/21065s4.PDF
Norethindrone acetate and ethinyl estradiol (EE) are rapidly absorbed from femhrt 1/ 5 tablets, with maximum plasma concentrations of norethindrone and ethinyl estradiol generally occurring 1 to 2 hours postdose
Mean (SD) Single- Dose (Day 1) and Steady- State (Day 87) Pharmacokinetic Parameters a Following Administration of 1 mg NA/ 10 mcg EE...
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http://www.fda.gov/cder/ogd/rld/21065s4.PDF page 4
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FDA Drug Approvals List October 1999
Drug Approvals for October 1999 Definitions and Notes Original New Drug Applications Original Application #: 021087 Approval Date: 27-OCT-99 Trade Name: TAMIFLU Chemical Type: 1 Therapeutic Potential: P Dosage Form: CAPSULE Applicant: HOFFMANN LA ROCHE INC Active Ingredient(s): OSELTAMIVIR PHOSPHATE OTC/RX Status: RX Indication(s): For the treatment of uncomplicated acute illness due...
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http://www.fda.gov/cder/foi/label/1999/21065LBLA.PDF
Norethindrone acetate and ethinyl estradiol 94 (EE) are rapidly absorbed from femhrt 1/ 5 tablets, with maximum plasma concentrations 95 of norethindrone and ethinyl estradiol generally occurring 1 to 2 hours postdose
Mean (SD) Single- Dose (Day 1) and Steady- State (Day 87) Pharmacokinetic Parameters a Following Administration of 1 mg NA/ 10...
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C:\Data\My Documents\drugs\estrogen\WHI labeling supps\femhrt\AP \ 21065 S-009.doc page 5
author: Bronwyn Collier
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http://www.fda.gov/cder/ogd/rld/21065s4.PDF page 9
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http://www.fda.gov/cder/ogd/rld/21065s4.PDF page 6
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http://www.fda.gov/cder/ogd/rld/21065s4.PDF page 5
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Pages
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.
Products Category ($ in millions) Allegra® Capsules Allergy 31 Allegra® Tablets Allergy 1,...
author: Lisa
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http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf
Barr Laboratories, Inc.
In May 2001, we filed an application for Flecainide Acetate tablets, a cardiovascular product, which is sold under the brand name Tambocor TM.
CyPat Clinical Study Cyproterone Acetate, which we intend to market in the United States under the name CyPat, is a steroid that blocks the action of testosterone.
In February 2000, we filed an...
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http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf page 15
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Drug Approvals - M
NDA 16-979/S-051 8/27/02 8/30/02 Megestrol Acetate Oral Suspension, 40 mg/mL., Rx Roxane Laboratories, Inc
ANDA 75-997 2/15/02 - - - Megestrol Acetate 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
ANDA 40-396 2/27/01 3/5/01 - - Micro-K and Micro-K 10...
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Drug Approvals - N
ANDA 40-455 3/3/03 Norethindrone Acetate Tablets USP, 5 mg, Rx Barr Laboratories, Inc
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 ...
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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...
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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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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 -...
author: Paul Stauffer
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