Microsoft Word - RPSepicPOM A Aciclovir 6 Acrivastine 6 Aluminium chloride 6 Aspirin 8, 46 Astemizole 5 Atropine Sulphate 9 Azelastine 8, B Beclomethasone Dipropionate 6, 47 Benzocaine 47 Benzoyl Peroxide 46 Budesonide 8 C Cadexomer- Iodine 8 Camphor 47 Carbenoxolone 6 Cetirizine 6,47 Cimetidine 6 Chloramphenicol 9 Clobetasone 9 Clotrimazole 6,8,46 Co- methiamol 29 D Dequalinium chloride 46 Dextranomer 5...
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 ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
First-Time Generics - August 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - August 2002 - Generic Drug Name Generic Manufacturer Brand Name Approval Date 1- NIFEDIPINE EXTENDED-RELEASE TABLETS, USP 90 MG BIOVAIL 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
FDA Drug Approvals List April 2001 - Drug Approvals for April 2001 Definitions and Notes Original New Drug Applications Original Application #: 020949 Approval Date: 30-APR-01 Trade Name: ACCUNEB Chemical Type: 5 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: DEY LABORATORIES INC Active Ingredient(s): ALBUTEROL SULFATE OTC/RX Status: RX Indication(s): For the treatment of asthma-related bronchospasm in...
Prescription and OTC Drug Product List 11/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 11: November 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE AMOXICILLIN - ADD - TABLET; ORAL TABLET; ORAL - ADD - TRIZIVIR AMOXICILLIN - ADD - + GLAXO WELLCOME EQ 300MG BASE;150MG;300MG N21205 001 - ADD -...
FDA Drug Approvals List- March 1999 Drug Approvals for March 1999 Definitions and Notes March 1999 Original New Drug Applications Original Application #: 020966 Approval Date: 30-MAR-99 Trade Name: SPORANOX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON Active Ingredient(s): ITRACONAZOLE OTC/RX Status: RX Indication(s): For the treatment of...
http://www.fda.gov/cder/foi/appletter/2000/75232ltr.pdf ANDA 75- 232 January 6, 2000 LLoperamide Hydrochloride Tablets USP, 2 mg (Caplets)
http://www.fda.gov/cder/foi/appletter/2000/75232ltr.pdf page 1
Drug and Device Approvals March 1995 74-322 CAPTOPRIL NOVOPHARM CAPTOPRIL 20-MAR-95 (TABLET) WILSON, NC 12.5MG 27396 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) 74-434 CAPTOPRIL MYLAN CAPTOPRIL 22-MAR-95 (TABLET) MORGANTOWN, WV 12.5MG 26505 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) 74-451 CAPTOPRIL ROYCE LABS CAPTOPRIL 31-MAR-95 (TABLET) MIAMI, FL 12.5MG 33014 25MG 50MG 100MG (ANGIOTENSIN...
FDA DRUG AND DEVICE PRODUCT APPROVALS 19-815 PROAMATINE ROBERTS PHARM MIDODRINE HYDROCHLORIDE 06-JUN-96 (TABLET) EATONTOWN, NJ 2.5MG 07724 5MG (ANTIHYPOTENSIVE) 20-519 LOPROX HOECHST MARION RSSL CICLOPIROX 02-JUL-96 (GEL) BRIDGEWATER, NJ 0.77% 08807 (ANTIFUNGAL) 20-584 LODINE XL WYETH AYERST ETODOLAC 03-JUL-96 (TABLET, PHILADELPHIA, PA 400MG EXTENDED RELEASE) 19101 600MG (NONSTEROIDAL ANTI-INFLAMMATORY) 20-453...
DDPA June 1996 50-719 HELIDAC KIT PROCTOR GAMBLE PHARM BISMUTH SUBSALICYLATE 05-JUN-96 (TABLET, CHEWABLE; CINCINNATI, OH 262.4MG/TABLET CHEWABLE TABLET; 45241 METRONIDAZOLE CAPSULE) 250MG/TABLET TETRACYCLINE 500MG/CAPSULE (ANTIULCER) 20-593 DEPACON ABBOTT VALPROATE SODIUM 06-JUN-96 (INJECTABLE) ABBOTT PARK, IL EQ 100MG ACID/ML 60064 (ANTICONVULSANT) 20-441 PULMICORT-200 ASTRA BUDESONIDE 14-JUN-96 ...
DDPA May 1996 20-509 GEMZAR ELI LILLY GEMCITABINE HYDROCHLORIDE 02-MAY-96 (INJECTABLE) INDIANAPOLIS, IN EQ 1MG BASE/VIAL 46285 (ANTINEOPLASTIC) 20-509 GEMZAR ELI LILLY GEMCITABINE HYDROCHLORIDE 02-MAY-96 (SOLUTION) INDIANAPOLIS, IN EQ 200MG BASE/VIAL 46285 (ANTINEOPLASTIC) 20-410 GASTROMARK ADVANCED MAGNETICS FERUMOXSIL 07-MAY-96 (SUSPENSION) CAMBRIDGE, MA EQ 0.175MG FE/ML 02138 (MRI...
DDPA March 1996 74-488 RANITIDINE HCL GRANUTEC RANITIDINE HYDROCHLORIDE 05-MAR-96 (TABLET) WILSON, NC EQ 150MG BASE 27896 EQ 300MG BASE (HISTAMINE H-2 RECEPTOR ANTAGONIST) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 04-570 HEPARIN SODIUM UPJOHN HEPARIN SODIUM 04-MAR-96 (INJECTABLE) KALAMAZOO, MI 1,000 UNITS/ML 49001 5,000 UNITS/ML 10,000 UNITS/ML (LABELING REVISION -- WARNINGS; PRECAUTIONS;...
Drug Approvals October 1996 Drug Approvals for October 1996 Definitions and Notes October 1996 Original New Drug Applications Original Application #: 019821 Approval Date: 28-OCT-96 Trade Name: SORIATANE Chemical Type: 2 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: HOFFMAN-LAROCHE Active Ingredient(s): ACITRETIN OTC/RX Status: RX Indication(s): Treatment of severe psoriasis Original Application #:...
July Drug Approvals Drug Approvals for July 1996 Definitions and Notes Original New Drug Application Original Application #: 020538 Approval Date: 31-JUL-96 Trade Name: ESTRADIOL Chemical Type: Already marketed drug product but a new manufacturer Therapeutic Potential: Standard review drug Dosage Form: FILM, EXTENDED RELEASE Applicant: MENOREST MANFACTURING INC Active Ingredient(s): ESTRADIOL OTC/RX...
Drug Approvals for July 1997 Drug Approvals for July 1997 Definitions and Notes July 1997 Original New Drug Applications Original Application #: 020701 Approval Date: 31-JUL-97 Trade Name: CRINONE Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: COLUMBIA RESEARCH LABORATORIES INC Active Ingredient(s): PROGESTERONE OTC/RX Status: RX Indication(s): Treatment of secondary amenorrhea Original...
Drug Approvals for June 1997 Drug Approvals for June 1997 Definitions and Notes June 1997 Original New Drug Applications Original Application #: 020729 Approval Date: 27-JUN-97 Trade Name: UNIRETIC Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: SCHWARZ PHARMA INC Active Ingredient(s): HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE OTC/RX Status: RX Indication(s): Treatment of...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, GANTANOL to LYSODREN Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS GANTANOL to LYSODREN Trade Name Generic GANTANOL Sulfamethoxazole GANTRISIN Sulfisoxazole GARAMYCIN Gentamicin GEOCILLIN Carbenicillin GLUCOPHAGE Metformin GLUCOTROL Glipizide GRIFULVIN V Griseofulvin GRISACTIN Griseofulvin HALCION Triazolam HALDOL Haloperidol HALDRONE Paramethasone HALOTESTIN...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Kanamycin to Moxalactam Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Kanamycin to Moxalactam Generic Trade Name Kanamycin KANTREX Ketoconazole NIZORAL Ketoprofen ORUDIS, ORUVAIL Ketorolac TORADOL Labetalol NORMODYNE, TRANDATE Lactulose CEPHULAC, CHRONULAC Lamivudine EPIVIR Lamotrigine LAMICTAL Lansoprazole PREVACID Latanoprost XALATAN Leflunomide ARAVA Levallorphan...
Diarrhea: Bowel Movement Disorders: Merck Manual Home Edition Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
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