AR 2007 Lo Res.pdf page 69
Pages Additional Patent Challenges During fiscal 2003, we announced five additional patent challenges, including challenges for: Eli Lilly's Evista® product for the treatment and prevention of osteoporosis in postmenopausal women; Kos Pharmaceutical's Niaspan® 500 mg and 750 mg extended release tablets for cholesterol; Ferring's patent related to DDAVP ® (...
author: Lisa
Pages page 5
author: Lisa
Drug Approvals - D NDA 18-841/S012 & 16 1/25/02 2/4/02 2/4/02 Daypro (oxyprozin) Caplets, 600 mg--- Pharmacia Corporation- NDA 18-841/S-020 4/9/03 4/16/03 4/16/03 DDAVP (desmopressin acetate) Nasal Spray, Injection & Tablets, Rx Aventis Pharmaceuticals NDA 17-922/S31, 18-938/S19 & 19-955/S5 11/12/03 11/25/03 - - DDAVP (desmopressin acetate) Injection, 4 µg/mL Aventis...
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...
http://www.fda.gov/cder/orange/appendix_a.txt 45, DIHYDROERGOTAMINE MESYLATE DACARBAZINE, DACARBAZINE DALGAN, DEZOCINE DALMANE, FLURAZEPAM HYDROCHLORIDE DANAZOL, DANAZOL DANOCRINE, DANAZOL DANTRIUM, DANTROLENE SODIUM DAPSONE, DAPSONE DARANIDE, DICHLORPHENAMIDE DARAPRIM, PYRIMETHAMINE DARBID, ISOPROPAMIDE IODIDE DARICON, OXYPHENCYCLIMINE HYDROCHLORIDE DARVOCET A500, ACETAMINOPHEN DARVOCET, ACETAMINOPHEN DARVOCET-N 100,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt "DIHYDROERGOTAMINE MESYLATE MANUFACTURED IN INGELHEIM, GERMANY" 10247 17-May-93 DIOSYNTH BV "PANCURONIUM BROMIDE MANUFACTURED IN OSS, THE NETHERLANDS" 10253 12-May-93 NEULAND LABORATORIES LTD "ALBUTEROL BASE MANUFACTURED IN BONTHAPALLI VILLIAGE, JINNARAM MANDAL, ANDHRA PRADESH, INDIA" 10262 25-May-93 JETPHARMA SA "CONTRACT MICRONIZATION SERVICES LOCATED IN BALERNA, SWITZERLAND" 10264...
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_%20APPROVED_AUG_1998.HTML Susp 12-813 S-043 Allergan 03-Aug-1998 PROVERA Medroxyprogesterone Acetate Tablets 11-839 S-068 Pharmacia And Upjohn 04-Aug-1998 OVCON-35 Ethinyl Estradiol/Norethindrone Tablets 18-127 S-033 Bristol-Myers Squibb 10-Aug-1998 OVCON-35 Ethinyl Estradiol/Norethindrone Tablets 17-716 S-045 Bristol-Myers Squibb 10-Aug-1998 OVCON-35 Ethinyl Estradiol/Norethindrone Tablets 17-756 S-045...
Prescription and OTC Drug Product List 9/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST -A- ADEFOVIR DIPIVOXIL -A- TABLET; ORAL -A- HEPSERA -A- + GILEAD 10MG N21449 001 SEP 20, 2002 SEP NEWA ALBUTEROL SULFATE TABLET, EXTENDED RELEASE; ORAL -A- ALBUTEROL SULFATE -A- AB SIDMAK LABS EQ 4MG BASE N76130 002 SEP 26, 2002 SEP NEWA -A- AB EQ 8MG BASE N76130 003 SEP 26, 2002 SEP NEWA VOLMAX -D- BC + MURO EQ 4MG BASE N19604...
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...
http://www.crha-health.ab.ca/clin/child/paed/KidsDoc/96winter.pdf page 2
Prescription and OTC Drug Product List October 1997 Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 10: Jan '97 - Oct '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE; ORAL OXYCODONE AND ACETAMINOPHEN TABLET;...
Prescription and OTC Drug Product List 1/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 1: January 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE BENDROFLUMETHIAZIDE; NADOLOL CAPSULE; ORAL TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN CORZIDE - ADD - AA MALLINCKRODT 500MG;5MG N88956 001 - ADD -...
FDA Drug Approvals List- March 1998 Drug Approvals for March 1998 Definitions and Notes March 1998 Original New Drug Applications Original Application #: 020827 Approval Date: 30-MAR-98 Trade Name: MONISTAT 3 Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: ADVANCED CARE PRODUCTS Active Ingredient(s): MICONAZOLE NITRATE OTC/RX Status: OTC Indication(s): For the over-the-counter treatment of...
http://www.fda.gov/cder/foi/appletter/2000/75220ltr.pdf ANDA 75- 220 August 28, 2000 Abbott Laboratories Attention: Kenneth Oh 200 Abbott Park Road, D- 389, AP30 Abbott Park, IL 60064- 6157 Dear Sir: This is in reference to your abbreviated new drug application dated September 30, 1997, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Desmopressin Acetate Injection, 4 mcg/ mL, packaged in...
http://www.fda.gov/cder/foi/appletter/2000/75220ltr.pdf page 1
http://www.fda.gov/cder/foi/appletter/2000/74574ltr.pdf ANDA 74- 574 February 18, 2000 Bedford Laboratories Attention: Shahid Ahmed 270 Northfield Road Bedford, OH 44146 Dear Sir: This is in reference to your abbreviated new drug application dated November 18, 1994, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Desmopressin Acetate Injection, 4 mcg/ mL, packaged in 1 mL ampules ...
http://www.fda.gov/cder/foi/appletter/2000/74574ltr.pdf page 2
duplicates:http://www.fda.gov/cder/foi/appletter/2000/74575ltr.pdf
http://www.fda.gov/cder/foi/appletter/2000/74574ltr.pdf page 1
http://www.fda.gov/cder/foi/appletter/2000/74575ltr.pdf ANDA 74- 575 February 18, 2000 Bedford Laboratories Attention: Shahid Ahmed 270 Northfield Road Bedford, OH 44146 Dear Sir: This is in reference to your abbreviated new drug application dated November 18, 1994, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Desmopressin Acetate Injection, 4 mcg/ mL, packaged in 10 mL vials
http://www.fda.gov/cder/foi/appletter/2000/74575ltr.pdf page 1
H:<830AP.PDF ANDA 74- 830 JAN 25, 1999 Bausch & Lomb Pharmaceuticals, IncDesmopressin Acetate Nasal Solution, 0.01%
author: Unknown
H:<830AP.PDF page 2
author: Unknown
FDA Drug Approvals List- August 1998 Approvable Original New Drug Applications Original Abbreviated New Drug Applications Original Abbreviated Application # 074951 Approval Date: 31-AUG-98 Trade Name: BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE Dosage Form: CAPSULE Applicant: JEROME STEVENS PHARMACEUTICALS INC Active Ingredient(s): ASPIRIN; BUTALBITAL; CAFFEINE; AND CODEINE PHOSPHATE OTC/RX Status: RX Original...
DDPA September 1995 DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S) APPROVAL DATE (DOSAGE FORM) STRENGTH(S) (CLASSIFICATION) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 16-968 MIOSTAT ALCON LABS CARBACHOL 18-AUG-95 (SOLUTION) FORT WORTH, TX 0.01% (SUPPL-013) 76134 (NEW INDICATION -- TO REDUCE THE...
