http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf Barr Laboratories, Inc.Flecainide Acetate tablets, a cardiovascular product, which is sold under the brand name Tambocor TM.Acetate, which we intend to market in the United States under the name CyPat, is a steroid that blocks the action of testosterone.
http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf page 18
http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf page 9
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® (Desmopressin ...
author: Lisa
Pages page 16
author: Lisa
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 RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLAGYL I.V., METRONIDAZOLE HYDROCHLORIDE FLAGYL, METRONIDAZOLE FLAREX, FLUOROMETHOLONE ACETATE FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE FLAVOXATE HCL, FLAVOXATE HYDROCHLORIDE FLAXEDIL, GALLAMINE TRIETHIODIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE FLEXICORT, HYDROCORTISONE...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt LISINOPRIL CRUDE AS MFG IN COURBEVOIE AND HAM FRANCE 14537 19-Nov-99 FUJISAWA PHARMACEUTICAL CO LTD FK8453 DRUG SUBSTANCE AS MFG IN HYOGO AND OSAKA JAPAN 14538 09-Nov-99 SICOR DE MEXICO SA DE CV AMCINONIDE AS MFG IN LERMA MEXICO 14539 18-Nov-99 "UQUIFA ITALIA, S.P.A." CLINDAMYCIN HYDROCHLORIDE USP AS MFG IN MILAN ITALY 14540 18-Nov-99 DIOSYNTH BV TESTOSTERONE UNDECANOATE AS MFG IN...
http://www.paddocklabs.com/images/PadSec7-1.pdf page 5
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AT ALLERGAN 1% N61187 001 JUN DISC >A> @ 1% N61187 001 JUN DISC >D> SOLUTION/DROPS; OPHTHALMIC >D> CHLOROPTIC >D> + ALLERGAN 0.5% N50091 001 JUN DISC >A> @ 0.5% N50091 001 JUN DISC >D> CHLOROQUINE HYDROCHLORIDE >D> INJECTABLE; INJECTION >D> ARALEN HCL >D> + SANOFI SYNTHELABO EQ 40MG BASE/ML N06002 002 JUN DISC >A> @ EQ 40MG BASE/ML N06002 002 JUN DISC CHLORPROMAZINE HYDROCHLORIDE...
author: AUTHOR
ANDA Tentative Approvals -July 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - July 2001 - - ANDA Number Drug Name Applicant Tentative Approval Date 1 75-416 NAPROXEN SODIUM EXTENDED-RELEASE TABLETS 375 MG (BASE) ANDRX PHARMACEUTICALS, INC
author: USERNAME
First-Time Generics -July 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - July 2001 - Approval Date Drug Name ANDA Number Supplement Number 7/3/01 CROMOLYN SODIUM NASAL SOLUTION, USP 5.2 MG DELIVERED/SPRAY, (40 MG/ML), 26 ML BOTTLE
author: USERNAME
ANDA Tentative Approvals -August 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - August 2001 - - ANDA Number Drug Name Applicant Tentative Approval Date 1 75-852 MILRINONE LACTATE INJECTION 1 MG (BASE)/ML BAXTER PHARMACEUTICAL PRODUCTS, INC
author: USERNAME
ANDA Drug Approvals - October 2002 -U.SACETATE TABLETS, USP 50 MG, 100 MG, AND...
author: OGD
ANDA Approvals January 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - January 2003 - ANDA Number- Generic Drug Name Applicant Approval Date 1 40-474 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/650 MG ABLE LABORATORIES, INC
author: OGD
Prescription and Over-the-Counter Drug Product List: 1/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE -A- SOLUTION; ORAL -A- ACETAMINOPHEN AND BUTALBITAL AND CAFFEINE -A- + MIKART 325MG/15ML;50MG/15ML;40MG/15ML N40387 001 JAN 31, 2003 JAN NEWA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPAHTE -A- AA ANDRX PHARMS 300MG;15MG N40443 001 JAN 22, 2003 JAN NEWA -A- AA...
author: AUTHOR
ANDA Approvals March 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - March 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-455 NOREPINEPHRINE BITARTRATE INJECTION, USP 1 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/4 ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC
author: OGD
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
FDA Drug Approvals List August 2001 Active Ingredient(s): PREDNISONE OTC/RX Status: RX Original Abbreviated Application # 075733 Approval Date: 22-AUG-01 Trade Name: CLOBETASOL PROPIONATE Dosage Form: EMULSION, CREAM Applicant: STIEFEL LABORATORIES INC Active Ingredient(s): CLOBETASOL PROPIONATE OTC/RX Status: RX Original Abbreviated Application # 074911 Approval Date: 22-AUG-01 Trade Name: PHRENILIN Dosage Form:...
FDA Drug Approvals List July 2001 - Drug Approvals for July 2001 Definitions and Notes Original New Drug Applications Original Application #: 021064 Approval Date: 31-JUL-01 Trade Name: DEFINITY Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTION Applicant: DUPONT PHARMACEUTICALS CO Active Ingredient(s): PERFLUTREN LI MICROSPHERE OTC/RX Status: RX Indication(s): For the treatment patients with suboptimal...
Prescription and OTC Drug Product List 7/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS 325MG;7.5MG...
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...
Microsoft Word - 76030ta.doc ANDA 76- 030 August 20, 2001 Geneva Pharmaceuticals Technology Corporation Attention: Mahendra Patel, PhFlecainide Acetate Tablets USP...
author: staufferp
Microsoft Word - 76030ta.doc page 1
author: staufferp
http://www.paddocklabs.com/forms/secundum/volume_6_1.pdf Loyd VFlecainide Acetate 20 Labetalol Hydrochloride 40 Metoprolol Tartrate 10 Verapamil Hydrochloride 50 Spironolactone and Hydrochlorothiazide 5/ 5 STABILITY OF EXTEMPORANEOUS...
