http://www.fda.gov/cder/orange/appendix_a.txt
3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN...
FDA Drug Approvals List August 2001
JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): COPPER OTC/RX Status: RX Application #:018612 Labeling Supplement#: 026 To Original New Drug Application Approval Date: 24-AUG-01 Trade Name: NICORETTE Dosage Form: GUM, CHEWING Applicant: SMITHKLINE BEECHAM CONSUMER HEALTHCARE LP Active Ingredient(s): NICOTINE POLACRILEX OTC/RX Status: RX Application #: 014879 Labeling...
Prescription and OTC Drug Product List 11/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 11: November 1999 [ Prescription - OTC ] - ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ALBUTEROL SULFATE BUPROPION HYDROCHLORIDE SOLUTION; INHALATION TABLET; ORAL ALBUTEROL SULFATE - ADD - BUPROPION HCL - ADD - AN MORTON GROVE EQ 0.083% BASE N75394 001 - ADD - AB TEVA 100MG...
FDA Drug Approvals List November 1999
Drug Approvals for November 1999 Definitions and Notes Original New Drug Applications Original Application #: 021035 Approval Date: 30-NOV-99 Trade Name: KEPPRA Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: UCB PHARMA INC Active Ingredient(s): LEVETRIACETAM OTC/RX Status: RX Indication(s): Provides for the use of Keppra as adjunctive therapy in the...
http://www.fda.gov/cder/foi/label/1999/20884lbl.pdf
AGGRENOX O O (aspirin/ extended- release dipyridamole) capsules DESCRIPTION AGGRENOX O is a combination antiplatelet agent intended for oral administrationDipyridamole Absorption: Peak plasma levels of dipyridamole are achieved 2 hours (range 1 6 hours) after administration of a daily dose of 400 mg AGGRENOX O (given as 200 mg bAspirin ...
http://www.fda.gov/cder/foi/label/1999/20884lbl.pdf page 15
http://www.fda.gov/cder/foi/label/1999/20884lbl.pdf page 10
http://www.fda.gov/cder/foi/label/1999/20884lbl.pdf page 8
http://www.fda.gov/cder/foi/label/1999/20884lbl.pdf page 7
http://www.fda.gov/cder/foi/label/1999/20884lbl.pdf page 3
http://www.fda.gov/cder/foi/label/1999/20884lbl.pdf page 2
http://www.fda.gov/cder/foi/label/1999/20884lbl.pdf page 1
FDA Drug Approvals List- June 1999
Drug Approvals for June 1999 Definitions and Notes June 1999 Original New Drug Applications Original Application #: 020968 Approval Date: 30-JUN-99 Trade Name: MONISTAT DUAL PAK Chemical Type: 3 Therapeutic Potential: S Dosage Form: SUPPOSITORY Applicant: ADVANCED CARE PRODUCTS Active Ingredient(s): MICONAZOLE NITRATE OTC/RX Status: RX Indication(s): TREATMENT OF VULVOVAGINAL...
20884_Aggrenox.htm
Food and Drug Administration Center for Drug Evaluation and Research Approval Package Search Aggrenox (Aspirin/Extended-Release Dipyridamole) Capsules Company:- Boehringer Ingelheim Pharmaceuticals, Inc Application No.:- 20884 Approval Date:-11/22/1999 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Part 1 - Part 2 - Chemistry Review(s) -...
author: Paul Stauffer
Transient Ischemic Attack (TIA) - Quest Diagnostics Patient Health Library
Transient Ischemic Attack (TIA) Medications Your doctor will probably prescribe several medicines after you have had a transient ischemic attack (TIA). Cholesterol-lowering and blood pressure-lowering medicines are also used to prevent TIAs and strokes. Antiplatelet medicines Antiplatelets (such as aspirin, aspirin with extended-release dipyridamole, or clopidogrel)...
Aspirin combined with extended-release dipyridamole for stroke and transient ischemic attack (TIA) - [Medication] - Quest
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Aspirin combined with extended-release dipyridamole for stroke and transient ischemic attack (TIA) - [Medication] - Quest Aspirin combined with extended-release dipyridamole for stroke and transient ischemic attack (TIA) - [Medication] - Quest...
Aspirin for stroke and transient ischemic attack (TIA) - [Medication] - Quest Diagnostics Patient Health Library
These antiplatelets include ticlopidine (Ticlid), clopidogrel (Plavix) , and aspirin combined with extended-release dipyridamole (Aggrenox). Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Aspirin for stroke and transient ischemic attack (TIA) - [Medication] - Quest Diagnostics...
Aspirin combined with extended-release dipyridamole for stroke and transient ischemic attack (TIA) - [Medication] - Quest
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Aspirin combined with extended-release dipyridamole for stroke and transient ischemic attack (TIA) - [Medication] - Quest Aspirin combined with extended-release dipyridamole for stroke and transient ischemic attack (TIA) - [Medication] - Quest...
doi:10.1016/j.thromres.2004.03.002
It has been established that aspirin, aggrenox (low- dose aspirin combined with the extended release dipyridamole), and ticlopidine reduce the frequency of secondary stroke events [3,4] The time interval between stroke occurrence and actual platelet studies was significantly Table 2 Platelet characteristics in patients after stroke, and subjects with multiple...
doi:10.1016/j.thromres.2004.03.002 page 2
Drug Approvals - A
NDA 20-913/S7 & 20-912/S8 9/25/01 4/22/02 - 4/22/02 Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection,12.5 mg per 50 mL vial & Premixed 25 mg per 500 mL single dose container, Rx Merck NDA 20-913/S6 & 20-912/S7 3/23/01 4/25/01 - - Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection, Rx Merck NDA 20-913/S4 & 20-912/S4 1/11/00 - - 6/6/01 Aggrastat ...
What's new at CDER by Date
MedWatch Safety Information Draft Guidance: Providing Regulatory Submissions in Electronic Format - Content of Labeling [ Word ] or [ PDF ] Inactive Ingredient Database (updated) Orange Book Query January 30, 2004 Approval Times for Priority and Standard NDAs - Calendar Years 1993-2003 (updated) Consumer Drug Information Sheets Cialis Drug Shortages Current Drug Shortages : Solu...
author: Paul Stauffer
N:\PM Folder\NDA ltrs\20-884 (Aggrenox)\20884s007.AP.doc page 1
author: Margaret Pease-Fye
Microsoft Word - Medication_Listing.doc
10 mg tab Autosubstitution to benazepril (ASL- 02) Continuing Care Pharmacy & Therapeutics Formulary ML- 01 SECTION SUBJECT Page 9 of 38 MEDICATION LISTING (ML) Medication Listing YY MM DD Original 00 10 30 Revised 02 01 14 Revised 03 10 23 digoxin (Lanoxin®) 0.0625 mg, 0.125 mg, 0.25 mg tab 0.05 mg/ mL oral liquid diltiazem (Cardizem®/ Tiazac®) 30 mg, 60 mg tab...
author: Wendy Daws
Microsoft Word - Master_Index.doc
Continuing Care Pharmacy & Therapeutics Formulary ML- Index SECTION SUBJECT Page 1 of 58 MASTER INDEX Medication Listing Index YY MM DD Original 00 10 30 Revised 01 12 19 Revised 03 10 23 DRUG NAME PAGE CLASS 5- FU Refer to Province Wide Services (PWS- 02) 35 84: 36 Abenol® 14 28: 08.92 Accupril® Restricted Status (RS- 08), Autosubstitution to benazepril or captopril (ASL-...
author: Wendy Daws