Drug Approvals - M ANDA 40-311 12/1/99 12/28/99 - - Mefloquine Hydrochloride Tablets, 250 mg, Rx Barr Laboratories ANDA 76-392 12/29/03 Mefloquine Hydrochloride Tablets, 250 mg, Rx, Tentatively Approved Roxane ANDA 76-523 9/12/03 Mefloquine Hydrochloride Tablets, 250 mg, Rx Geneva Pharamaceuticals- ANDA 76-175 2/20/02 4/11/03 - 8/6/03 Megace (megestrol acetate) Oral Suspension,-Rx Bristol...
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 PEDIATRIC, ASCORBIC ACID M.V.I.-12 LYOPHILIZED, ASCORBIC ACID M.V.I.-12, ASCORBIC ACID MACROBID, NITROFURANTOIN MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE MACROTEC, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT MAGNACORT, HYDROCORTAMATE HYDROCHLORIDE MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE...
FDA Drug Approvals List April 2002 JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): HALOPERIDOL OTC/RX Status: RX Application #: 011340 Labeling Supplement #: 016 To Original New Drug Application Approval Date: 17-APR-02 Trade Name: CERUMENEX Dosage Form: SOLUTION Applicant: PURDUE FREDERICK CO Active Ingredient(s): TRIETHANOLAMINE POLYPEPTIDE OLEATE CONDENSATE OTC/RX Status: OTC Application #: 010596...
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...
RLD_LABELING_APPROVED_NOV_1999 Firm Date AMINOHIPPURATE Na Na Aminohippurate 5-619 S-015 Merck 2-Nov-1999 FLOLAN Epoprostenol Na Injection 20-444 S-004 Glaxo Wellcome 2-Nov-1999 DEXEDRINE Dextroamphetamine SO4 ER Capsules 17-078 S-034 SmithKline Beecham 3-Nov-1999 ZOLADEX Goserelin Acetate Implant 20-578 S-009 Zeneca 3-Nov-1999 ZOLADEX Goserelin Acetate Implant 3.6 Mg 19-726 S-030 Zeneca 3-Nov-1999...
APPROVED LABELING NDA 16-979/S-049 The empirical formula is C24 H32 O4 and the structural formula is represented as follows: MEGACE is supplied as tablets for oral administration containing 20 mg and 40 mg megestrol acetatemegestrol acetate given as a 40 mg qid regimen, the oral absorption of MEGACE appeared to be variable
author: JFG
subject: MEGACE (MEGESTROL ACETATE TABLETS)
APPROVED LABELING NDA 16-979/S-049 page 4
author: JFG
subject: MEGACE (MEGESTROL ACETATE TABLETS)
APPROVED LABELING NDA 16-979/S-049 page 3
author: JFG
subject: MEGACE (MEGESTROL ACETATE TABLETS)
APPROVED LABELING NDA 16-979/S-049 page 2
author: JFG
subject: MEGACE (MEGESTROL ACETATE TABLETS)
APPROVED LABELING NDA 16-979/S-049 page 1
author: JFG
subject: MEGACE (MEGESTROL ACETATE TABLETS)
LABELING SUPPLEMENT APPROVAL LETTER NDA 16-979/S-049 page 2
author: JFG
subject: MEGACE (MEGESTROL ACETATE TABLETS)
LABELING SUPPLEMENT APPROVAL LETTER NDA 16-979/S-049 page 1
author: JFG
subject: MEGACE (MEGESTROL ACETATE TABLETS)
FDA Drug Approvals List January 2001 - Drug Approvals for January 2001 Definitions and Notes Original New Drug Applications Original Application #: 021208 Approval Date: 12-JAN-01 Trade Name: REMERON SOLTAB Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET, ORALLY DISINTEGRATING Applicant: ORGANON INC Active Ingredient(s): MIRTAZAPINE OTC/RX Status: RX Indication(s): For the treatment of depression Original...
http://www.fda.gov/cder/foi/appletter/2000/75671ta.pdf ANDA 75- 671 October 23, 2000 Par Pharmaceutical, IncMegestrol Acetate Oral Suspension, 40 mg/ mL...
http://www.fda.gov/cder/foi/appletter/2000/75671ta.pdf page 1
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 #:...
Drug Approvals for September 1997 The development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program Original Application #: 020857 Approval Date: 26-SEP-97 Trade Name: COMBIVIR Chemical Type: 4 Therapeutic Potential: P Dosage Form: TABLET Applicant: GLAXO WELLCOME INC Active Ingredient(s): LAMIVUDINE; ZIDOVUDINE OTC/RX Status: RX Indication(s): Treatment...
Drug Approvals for August 1997 Drug Approvals for August 1997 Definitions and Notes August 1997 Original New Drug Applications Original Application #: 020808 Approval Date: 29-AUG-97 Trade Name: VISIPAQUE Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: NYCOMED INC Active Ingredient(s): IODIXANOL OTC/RX Status: RX Indication(s): Intra-arterial - for visceral intra-arterial digital...
Generic Names of Some Trade Name Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs -~ Generic Names of Some Trade Name Drugs - Generic Names of Some...
Some Trade Names of Generic Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs-~ Generic Names of Some Trade Name Drugs - Some Trade Names of...
Cancer: Breast 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...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, MACRODANTIN to NYTOL Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS MACRODANTIN to NYTOL Trade Name Generic MACRODANTIN Nitrofurantoin MANDELAMINE Methenamine MANDOL Cefamandole MAREZINE Cyclizine MARINOL Dronabinol MATULANE Procarbazine MAVIK Trandolapril MAXALT Rizatriptan MAXAQUIN Lomefloxacin MAZANOR Mazindol MECLOMEN Meclofenamate MEDROL Methylprednisolone...
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...
Human Immunodeficiency Virus Infection: 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...
