IROA - Scientific Study Reference Search Pellets 2-Acetamidofluorene (2-AAF) 2-Acetylaminofluorene (AAF) 2-OHE1 3,3',5-Triiodo-L-Thyronine (T3) 4-Hydroxyandrostene-3,17-dione (4-OHA) 4-Hydroxyandrostenedione 5a-Androstan-3a + 17ss-diol 5a-Dihydrotestosterone (5a-DHT) 5a-Dihydrotestosterone (5a-DHT) 5a-Reductase Inhibitor (4MA) 5-Bromo-2'-Deoxyurdine (BrDU) 5a-Dihydrotestosterone (5a-DHT) 6-n-Propyl-2-Thiouracil (PTU...
Office of Generic Drugs: News, Announcements and Federal Register Notices from 2002 -- (Posted 8/27/2003) Shared Exclusivity for Paroxetine Hydrochloride Tablets [ HTML ] or [ Word ]-- (Posted 8/4/2003) On June 26, 2003, a Generic Pharmaceutical Association/Office of Generic Drugs joint meeting was held as a collaborative effort directed at improving the Generic Drug Approval Process.- Meeting agenda and presentations
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...
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...
http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt PETERSBURG, FL" 12840 02-Feb-98 GRUPPO LEPETIT SPA "OXYBUTYNIN CHLORIDE, MANUFACTURED IN GARESSIO,ITALY" 12848 05-Feb-98 JOHNSON MATTHEY INC "HYDROCODONE BITARTRATE, USP MANUFACTURED IN WEST DEPTFORD, NEW JERSEY." 12851 05-Feb-98 PFANSTIEHL LABORATORIES INC "DECITABINE, MANUFACTURED IN WAUKEGAN,IL." 12854 10-Feb-98 YAMANOUCHI PHARMACEUTICAL CO LTD "YM087 DRUG SUBSTANCE, MANUFACTURED...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls IN BUDAPEST, HUNGARY PLANTEX LTD CHEM AND PHARM WORKS IMIPRAMINE HYDROCHLORIDE LUNDBECK PHARMACEUTICALS ITALY SPA IMIPRAMINE HYDROCHLORIDE AVENTIS PHARMA SA PROMETHAZINE HCL GRUPPO LEPETIT SPA D-PROPOXYPHENE HYDROCHLORIDE BULK SCHERING AG ETHINYL ESTRADIOL ROCHE COLORADO CORPORATION
http://www.fda.gov/cder/dmf/text/4Q2003NEWTEXT.txt CHINA." 16892 V 3-Sep-2003 ALTHEA TECHNOLOGIES INC "ASEPTIC FORMULATION, FILL, AND FINISH FACILITY IN SAN DIEGO, CA." 16893 III 15-Sep-2003 ERIE MOLDED PLASTICS INC "LID FOR DEODORANT AS MANUFACTURED IN ERIE, PA." 16894 II 5-Oct-2003 DIVIS LABORATORIES LTD "LEVITERACETAM AS MANUFACTURED IN ANDHRA PRADESH, INDIA." 16895 IV 6-Oct-2003 FIRMENICH INC "NATURAL & ARTIFICIAL ORANGE FLAVOR...
http://www.fda.gov/cder/dmf/xls/4Q2003NEWEXCEL.xls II RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA SERTRALINE HYDROCHLORIDE FORM II AS MANUFACTURED IN CAMPOVERDE DI APRILIA (LT), ITALYHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA II NICHOLAS PIRAMAL INDIA LTD ITRACONAZOLE AS MANUFACTURED IN ANDHRA...
http://www.paddocklabs.com/forms/secundum/volume_9_2.pdf Rx Fentanyl 35 µg/ mL, Bupivacaine 1 mg/ mL and Clonidine 9 µg/ mL Intrathecal Solution Fentanyl 3.5 mg* Bupivacaine hydrochloride 100 mg Clonidine 900 µg 0.9% Sodium chloride injection qs 100 mL *commercial preservative- free injectable Fentanyl labeled as Fentanyl base/ mLClonidine Hydrochloride Epidural Injection...
http://www.paddocklabs.com/forms/secundum/volume_9_2.pdf page 4
Prescription and OTC Drug Product List 9/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- ENDO PHARMS 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -D- 400MG;7.5MG N40288 002 NOV 27, 1998 SEP CTEC -D- 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -A- + 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;7.5MG...
Prescription and OTC Drug Product List 12/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE TABLET; ORAL PRECOSE -D- BAYER 25MG N20482 004 MAY 29, 1997 DEC CAHN -D- 50MG N20482 001 SEP 06, 1995 DEC CAHN -D- + 100MG N20482 002 SEP 06, 1995 DEC CAHN -A- BAYER PHARMS 25MG N20482 004 MAY 29, 1997 DEC CAHN -A- 50MG N20482 001 SEP 06, 1995 DEC CAHN -A- + 100MG N20482 002 SEP 06, 1995 DEC CAHN ACYCLOVIR -A- CREAM;...
Prescription and OTC Drug Product List 10/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;7.5MG N40464 001 OCT 23, 2002 OCT NEWA -A- AA 325MG;10MG N40464 002 OCT 23, 2002 OCT NEWA -A- AA 650MG;10MG N40476 001 OCT 23, 2002 OCT NEWA -A- AA 750MG;7.5MG N40469 001 OCT 25, 2002 OCT NEWA -A- AA MALLINCKRODT 750MG...
TIMPILO Product Monograph PRODUCT MONOGRAPH TIMPILO ® (timolol maleate and pilocarpine hydrochloride ophthalmic solution) Sterile Olphthalmic Solution THERAPEUTIC CLASSIFICATION ELEVATED INTRAOCULAR PRESSURE THERAPY DESCRIPTION TIMPILO ® (timolol maleate and pilocarpine hydrochloride) is a fixed combination of timolol maleate 0.5% and pilocarpine hydrochloride 2% (TIMPILO ® 2) or 4% (TIMPILO &...
author: Merck Frosst Canada & Co.
subject: 644-a,5,00
COSOPT - Product Monograph Clonidine Oral ss- adrenergic blocking agents may exacerbate the rebound hypertension which can follow the withdrawal of clonidineHydrochloride Headache; eyelid inflammation; eyelid crusting; nausea; eyelid irritation;...
author: Merck Frosst Canada Ltd.
subject: 778-b,11,02
http://www.merck.com/product/usa/pi_circulars/c/cosopt/cosopt_pi.pdf 9359301 1 COSOPT ® (dorzolamide hydrochloride- timolol maleate ophthalmic solution) Sterile Ophthalmic Solution DESCRIPTION COSOPT * (dorzolamide hydrochloride- timolol maleate ophthalmic solution) is the combination of a topical carbonic anhydrase inhibitor and a topical beta- adrenergic receptor blocking agent
SSCI Inc.: X-ray Powder Diffraction, Raman and Infrared Spectroscopy, Differential Scanning Calorimetry, and Thermogravimetric Phone: 800 375-2179 / 765 463-0112 Fax: 765 497-2649 / 765 463-4722 E-mail: info@ssci-inc.com SSCI Inc., 3065 Kent Avenue, West Lafayette, IN 47906 - 1076 USA Acetaminophen Acetazolamide Acetohexamide Acetylcysteine Acyclovir Adenine L-Alanine Albuterol Albuterol Sulfate Allopurinol Alprazolam Amantadine HCl Amiloride HCl Aminobenzoic Acid Aminoglutethimide Aminosalicylic Acid...
author: SSCI Webmaster
Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 28
author: FDA
Quarterly List of Guidance Documents at the Food and Drug Administration page 12
author: FDA
N:\Lisa\merck\NDA20869\12n20869let.doc 3 COSOPT ® (dorzolamide hydrochloride- timolol maleate ophthalmic solution) Sterile Ophthalmic Solution DESCRIPTION COSOPT* (dorzolamide hydrochloride- timolol maleate ophthalmic solution) is the combination of a topical carbonic anhydrase inhibitor and a topical beta- adrenergic receptor blocking agent
author: Lisa Hubbard
Prescription and OTC Drug Product List 12/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 12: December 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE ALBUTEROL SULFATE - ADD - SOLUTION; ORAL SOLUTION; INHALATION - ADD - ZIAGEN ALBUTEROL SULFATE - ADD - + GLAXO WELLCOME EQ 20MG BASE/ML N20978 001 - ADD - @ COPLEY PHARM...
Prescription and OTC Drug Product List 8/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 8: August 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MODURETIC 5-50 - ADD - AB...
SUPAC Chair, CMC CC Appendix A Narrow Therapeutic Range Drugs Aminophylline Tablets, ER Tablets Carbamazepine Tablets, Oral Suspension Clindamycin Hydrochloride Capsules Clonidine Hydrochloride Tablets Clonidine Transdermal Patches Dyphylline Tablets Disopyramide Phosphate Capsules, ER Capsules Ethinyl Estradiol/Progestin Oral Contraceptive Tablets Guanethidine...
FDA Drug Approvals List- April 1999 Original Application #: 050760 Approval Date: 15-APR-99 Trade Name: AMOXIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: SUSPENSION Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): AMOXICILLIN OTC/RX Status: RX Indication(s):For the use of Amoxil for oral suspension 200mg/5mL and 400mg/5mL in divided doses q12h Original Application #: 020924 Approval Date:...
