Drug Approvals - M
ANDA 75-243 8/31/99 9/2/99 - - Midazolam Hydrochloride Injection,1 mg (base)/mL & 5 mg (base)/mL, Rx Bedford Laboratories ANDA 75-247 6/23/00 10/31/00 - - Midazolam Hydrochloride Injection,1 mg (base)/mL & 5 mg (base)/mL Tentatively Approved Bedford Laboratories ANDA 75-247 9/30/99 10/4/99 - - Midazolam Hydrochloride Injection,5 mg (base)/mL, Rx Bedford Laboratories...
http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
IN LAHR, GERMANY" 6291 25-Apr-86 BACHEM FEINCHEMIKALIEN AG DECAPEPTYL AS MFG BUBENDORF/SWITZERLAND 6309 05-May-86 FINE CHEMICALS CORPORATION "THIOTHIXENE AS MFG IN CAPE PROVINCE, SOUTH AFRICA" 6315 10-Mar-86 NYCOMED AUSTRIA GMBH MIDODRINE HYDROCHLORIDE 6318 04-Mar-86 NORAMCO OF DELAWARE INC "OXYCODONE HYDROCHLORIDE AS MFG OF IRELAND" 13266 05-Oct-98 FABBRICA...
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 METFORMIN HYDROCHLORIDE (LA 6023) BOEHRINGER INGELHEIM CHEMICALS INC...
../2002/19-815S005_ProAmatine Midodrine 20 Hydrochloride
Food and Drug Administration Center for Drug Evaluation and Research Title Search ProAmatine (Midodrine Hydrochloride) Tablets Company:--Shire Laboratories Inc Application No.:--19-815/S5 Approval Date:-3/20/2002 Approval Letter(s) - Printed Labeling - Chemistry Review(s) - Clinical Pharmacology Biopharmaceutics Review(s) - Correspondence - - Back to Drug...
author: USERNAME
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004
- TABLET; CHEWABLE Approved 5/8/2001- CARBOPLATIN 50 MG/5 ML ;10MG/ML 150 MG/15 ML;10MG/ML - 01P-0036/CP1 VENABLE - INJECTION Approved 11/30/2001- MIDODRINE HYDROCHLORIDE 15 MG - 01P-0081/CP1 LACHMAN CONSULTANT SERVICES - TABLET; ORAL Approved 5/8/2001- HYDROCORTISONE ACETATE 2% - 01P-0085/CP1 FERNDALE LABORATORIES INC - TABLET; ORAL Approved 2/28/2003- BACLOFEN 10 mg,...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004
SAIF - TABLETS Pending - METOPROLOL TARTRATE 25 mg - 02P-0460/CP1 CARACO PHARMACEUTICAL - TABLETS Approved 2/13/2003- METOPROLOL TARTRATE 25 mg - 02P-0459/CP1 LACHMAN CONSULTANT SERVICES - TABLETS Approved 2/13/2003- MIDAZOLAM 5 MG/ML-10 ML VIALS - 01P-0136/CP1 ABBOTT LABORATORIES - INJECTION Approved 8/5/2002- MIDODRINE HYDROCHLORIDE 15 MG - 01P-0081/CP1 LACHMAN...
ANDA Approvals - September 2003
9/5/2003- 8 76-514 MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG AND 5 MG - EON LABS, INC 9/10/2003- 12 76-429 PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/500 MG - AAI PHARMA 9/10/2003- 13 76-577 MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG, 5 MG, AND 10 MG - MYLAN PHARMACEUTICALS, INC 9/16/2003- 21 76-409 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG...
Prescription and Over-the-Counter Drug Product List: 9/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> + MIKART 325MG/15ML;7.5MG/15ML N40482 001 SEP 25, 2003 SEP NEWA ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL >A> OXYCODONE AND ACETAMINOPHEN >A> AA WATSON LABS 325MG;7.5MG N40535 001 SEP 05, 2003 SEP NEWA >A> AA 325MG...
author: AUTHOR
NDAs Approved under Subpart H
NDAs Approved under Subpart H NDA # Trade Name Generic -Name Clock Date Approval Date AP Time Approval Basis Indication - - - - - - - - 20199 Hivid Zalcitabine 31-Oct-91 19-Jun-92 7.6 S Combination therapy with zidovudine in advanced HIV infection - - - - - - - - 50698 Biaxin Clarithromycin- 2-Nov-92 23-Dec-93 13.7 S Treatment of disseminated mycobacterial infections due to...
author: Darlene Norris
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...
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 6/2002
-A- + GD SEARLE LLC EQ 500MG BASE/VIAL N18353 001 JUL CAHN -D- + SCS EQ 500MG BASE/VIAL N18353 001 JUL CAHN MIDAZOLAM HYDROCHLORIDE INJECTABLE; INJECTION MIDAZOLAM HCL -A- AP ABBOTT EQ 1MG BASE/ML N75857 001 JUL 22, 2002 JUL NEWA -A- AP EQ 5MG BASE/ML N75857 002 JUL 22, 2002 JUL NEWA MIDODRINE HYDROCHLORIDE TABLET; ORAL PROAMATINE -A- + SHIRE LABS 5MG N19815 002 SEP...
Prescription and OTC Drug Product List 6/2002
-D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
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...
Drug Approvals September 1996
Drug Approvals for September 1996 Definitions and Notes Original New Drug Applications Original Application #: 020592 Approval Date: 30-SEP-96 Trade Name: ZYPREXA Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: ELI LILLY AND CO Active Ingredient(s): OLANZAPINE OTC/RX Status: RX Indication(s): MANAGEMENT OF THE MANIFESTATIONS OF PSYCHOTIC DISORDERS Original...
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...
Index M, 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 - INDEX - Index-A -~ Index-B -~ Index-C -~ Index-D -~ Index-E -~ Index-F -~ Index-G -~ Index-H -~ Index-I -~ Index-J -~ Index-K -~ Index-L -~ Index-M-~ Index-N -~ Index-O ...
Shy-Drager Syndrome, Movement Disorders, 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 - SECTION 3 Medical Conditions CHAPTER 30 - Movement Disorders TOPICS - Introduction -~ Myoclonus -~ Dystonia -~ Tardive Dyskinesia and Akathisia -~ Essential Tremor -~...
Shy-Drager Syndrome: Movement Disorders: Merck Manual Home Edition
Section Brain, Spinal Cord, and Nerve Disorders Subject Movement Disorders Shy-Drager Syndrome Shy-Drager syndrome (idiopathic orthostatic hypotension) results in tremor when muscles are at rest (resting tremor) and in malfunction of the autonomic nervous system, including pronounced instability of blood pressure. The cause of the degeneration is unknown. It is similar to...
Orthostatic Hypotension: Low Blood Pressure: Merck Manual Home Edition
Section Heart and Blood Vessel Disorders Subject Low Blood Pressure Orthostatic Hypotension Orthostatic hypotension is an excessive decrease in blood pressure that occurs when a person stands up, resulting in reduced blood flow to the brain and dizziness or fainting. If these compensatory mechanisms malfunction or function too slowly—both of which commonly occur in older...
Index: MI: 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, Sec. 16, Ch. 200, Orthostatic Hypotension And Syncope
This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 16. The initial manifestations of decreased tissue perfusion are the effects of impaired cerebral blood flow; however, postural BP changes do not reliably reflect cerebral hypoperfusion. -Adrenergic blockers are a rare cause, but -adrenergic blockers such as prazosin may be causative, especially...
THE MERCK MANUAL OF GERIATRICS, Index M
- Index Index-A -| Index-B -| Index-C -| Index-D -| Index-E -| Index-F -| Index-G -| Index-H -| Index-I -| Index-J &n; bsp;| Index-K -| Index-L -| Index-M -| Index-N -| Index-O -| Index-P -| Index-Q -| Index-R -| Index-S -| Index-T -| Index-U -| Index-V -| Index-W -| Index-X,Y,Z Index M Macrocytic anemia 674t , 684-687 Macroglobulinemia (Waldenstroem's) 737-739 Macrolides 1371t...