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 ACETAMINOPHEN,...
DDPA November 1995 20-469 BECLOMETHASONE SCHERING BECLOMETHASONE DIPROPIONATE 09-NOV-95 DIPROPIONATE KENILWORTH, NJ MONOHYDRATE MONOHYDRATE 07033 EQ 0.084MG DIPROP/INH (SPRAY, METERED) (STEROID) 20-539 LAMISIL SANDOZ TERBINAFINE HYDROCHLORIDE 21-NOV-95 (TABLET) EAST HANOVER, NJ EQ 250MG BASE 07936 (ANTIFUNGAL) 20-291 COMBIVENT BOEHRINGER INGELHEIM ALBUTEROL SULFATE 22-NOV-95 (AEROSOL,...
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 #:...
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 ...
1997 Warning Letters and Notice of Violation Letters to Pharmaceutical Companies DDMAC 5/30/1997 6/13/1997 Proventil-HFA (Albuterol Sulfate Inhalation Schering Corporation DDMAC 5/7/1997 5/16/1997 Uni-Dur (theophylline) extended release tablets Schering Corporation DDMAC 5/13/1997 6/3/1997 June 1997 Benefin Lane Labs-USA DDMAC 6/13/1997 6/3/1998 Efedrin (Maximum Strength) The Hammer Corporation DDMAC 6/10/1997 6/16/1997 Effexor (vanlafaxine HCl)...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt IN ZOFINGEN, SWITZERLAND" 8973 18-Feb-91 SIFAVITOR SPA "IPRATROPIUM BROMIDE MANUFACTURED IN MILAN, ITALY." 8974 22-Feb-91 KINERTON LTD "SOMATULINE (BIM 23014C) AS MFGIPRATROPIUM BROMIDE MONOHYDRATE AS MANUFACTURED IN INGLEHEIM AM RHEIN GERMANY 14267 06-Jul-99 DIOSYNTH BV EPTIFIBATIDE AS MANUFACTURED IN THE NETHERLANDS 14269 06-Jul-99 POLI INDUSTRIA CHIMICA...
Prescription and Over-the-Counter Drug Product List: 11/2003 ACTHAR GEL >D> BC + QUESTCOR PHARMS 80 UNITS/ML N08372 008 NOV CTEC >A> + 80 UNITS/ML N08372 008 NOV CTEC CYTARABINE INJECTABLE; INJECTION >D> CYTARABINE >D> AP + GENSIA SICOR PHARMS 100MG/VIAL N16793 001 NOV DISC >D> AP + 500MG/VIAL N16793 002 NOV DISC >D> AP + 1GM/VIAL N16793 003 DEC 21, 1987 NOV DISC >D> AP + 2GM/VIAL N16793 004 DEC 21, 1987 NOV DISC >A> @ SICOR PHARMS 100MG/VIAL...
Prescription and Over-the-Counter Drug Product List: 4/2003 45 -D- XCEL PHARMS 1MG/ML N05929 001 APR CFTG -A- AP + 1MG/ML N05929 001 APR CFTG -A- DIHYDROEROGTAMINE MESYLATE -A- AP PADDOCK 1MG/ML N40475 001 APR 28, 2003 APR NEWA DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL -A- TAZTIA XT -A- AB4 ANDRX PHARMS 120MG N75401 001 APR 10, 2003 APR NEWA -A- AB4 180MG N75401 002 APR 10, 2003 APR NEWA -A- AB4 240MG N75401 003 APR 10, 2003 APR...
author: AUTHOR
Efficacy Supplements Approved in Calendar Year 1998 EFFICACY SUPPLEMENTS APPROVED IN CY 98 GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPPLEMENT TYPE TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION ACARBOSE BAYER 20-482 30-Sep-97 29-Sep-98 SE1 12.0 For patients with type 2 diabetes treated with diet plus insulinALBUTEROL SULFATE 3M PHARMACEUTICALS 20-503 26-Sep-97 23-Sep-98 SE1 11.9 Prevention of...
author: Brenda Harmon
ANDA Approvals April 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - April 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 76-391 ALBUTEROL SULFATE INHALATION SOLUTION 0.5% (BASE) NOVEX PHARMA 4/1/2003- 2 76-371 TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) AND 4 MG (BASE) BARR LABORATORIES, INC
author: OGD
NDA Approvals for Calendar Year 2001 Braun 5 S 21-Feb-01 21-235 Prozac Weekly Fluoxetine Hydrochloride Eli Lilly 3 S 26-Feb-01 21-169 Reminyl Galantamine Hydrobromide Janssen Research 1 S 28-Feb-01 21-082 Tavist Allergy/Sinus/Headache Acetaminophen/Clemastine Fumarate/Pseudoephedrine Hydrochloride Novartis 4 S 01-Mar-01 21-257 Travatan Travoprost Alcon 1 P 16-Mar-01 21-262 Alphagan P Brimonidine Tartrate Allergan 3 S 16...
author: Brenda Harmon
FDA Drug Approvals List March 2001 - Drug Approvals for March 2001 Definitions and Notes Original New Drug Applications Original Application #: 021304 Approval Date: 29-MAR-01 Trade Name: VALCYTE Chemical Type: 2 Therapeutic Potential: P Dosage Form: TABLET Applicant: SYNTEX (USA) INC LLC Active Ingredient(s): VALGANCICLOVIR HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of cytomegalovirus (CMV)...
Prescription and OTC Drug Product List 10/2001 PEDIATRIC -D- + ASTRAZENECA 80MG/VIAL;0.02MG/VIAL;0.00 1MG/VIAL;5MG/VIAL;0.01MG/V IAL;0.14MG/VIAL;17MG/VIAL; 0.2MG/VIAL;1MG/VIAL;1.4MG/ VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/V IAL N18920 001 SEP 21, 2000 OCT CAHN -A- + NEOSAN PHARMS 80MG/VIAL;0.02MG/VIAL;0.00 1MG/VIAL;5MG/VIAL;0.01MG/V IAL;0.14MG/VIAL;17MG/VIAL; 0.2MG/VIAL;1MG/VIAL;1.4MG/ VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/V IAL...
Lovelace Respiratory Research Institute - Directory of Scientists Directory of Scientists Management 2003 Board of Directors Research Program Oversight Committee - - CONWAY, MARTIN J., MD - CONTACT INFORMATION Fax: (505) 348-8546 e-mail: mconway@lrri.org 9/02 EDUCATION B.S
http://www.paddocklabs.com/forms/secundum/volume_6_3.pdf page 6
http://www.paddocklabs.com/forms/secundum/volume_6_3.pdf page 5
Prescription and OTC Drug Product List 1/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 1: Jan 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE ALPROSTADIL TABLET; ORAL INJECTABLE; INJECTION PRECOSE PROSTIN VR PEDIATRIC - DLT - @ BAYER 25MG N20482 004 - DLT - + PHARMACIA AND UPJOHN 0.5MG/ML N18484 001 - DLT - MAY 29, 1997 - ADD -...
Prescription and OTC Drug Product List 3/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 3: January-March 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ATORVASTATIN CALCIUM CAPSULE; ORAL TABLET; ORAL - ADD - BUTALBITAL; ACETAMINOPHEN; AND CAFFEINE WITH CODEINE LIPITOR - ADD - PHOSPHATE ...
FDA Drug Approvals List- May 1999 Efficacy Supplemental New Drug Applications Application #: 020584 Efficacy Supplement#: 003 Type: SE2 to Original New Drug Application Approval Date: 27-MAY-99 Trade Name: LODINE XL Dosage Form: TABLET, EXTENDED RELEASE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): ETODOLAC OTC/RX Status: RX Efficacy Claim: For the management of the signs and symptoms of...
FDA Drug Approvals List- November 1998 Drug Approvals for November 1998 Definitions and Notes November 1998 Original New Drug Applications Original Application #: 021008 Approval Date: 25-NOV-98 Trade Name: SANDOSTATIN LAR Chemical Type: 3 Therapeutic Potential: P Dosage Form: INJECTABLE Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP Active Ingredient(s): OCTREOTIDE ACETATE OTC/RX Status: RX...
Beta2-agonists for chronic obstructive pulmonary disease (COPD) - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Beta2-agonists for chronic obstructive pulmonary disease (COPD) - [Medication] - Quest Diagnostics Patient Health Library Beta2-agonists for chronic obstructive pulmonary disease (COPD) - [Medication] - Quest Diagnostics Patient Health Library Advair Diskus,...
Beta2-agonists for chronic obstructive pulmonary disease (COPD) - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Beta2-agonists for chronic obstructive pulmonary disease (COPD) - [Medication] - Quest Diagnostics Patient Health Library Beta2-agonists for chronic obstructive pulmonary disease (COPD) - [Medication] - Quest Diagnostics Patient Health Library Advair Diskus,...
Anticholinergics for chronic obstructive pulmonary disease (COPD) - [Medication] - Quest Diagnostics Patient Health Library Anticholinergics for chronic obstructive pulmonary disease (COPD) Examples Prescription anticholinergics Brand Name Chemical Name Atrovent ipratropium bromide (short-acting) Prescription anticholinergic and short-acting beta2-agonist combination Brand Name Chemical Name Combivent, DuoNeb ipratropium bromide and albuterol sulfate How It Works Anticholinergics...
Anticholinergics for asthma - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Anticholinergics for asthma - [Medication] - Quest Diagnostics Patient Health Library Anticholinergics for asthma - [Medication] - Quest Diagnostics Patient Health Library Allergies and asthma, Immune system, Lungs and airways, acute asthma, Albuterol, ...
Pediatric Advisor 2004.2: Bronchodilator: Short-Acting Beta2-Agonist Pediatric Health Topics | All Health Topics Mott Children's Hospital | Pediatric Services Find a UMHS Doctor Search Pediatric Topics Search All Topics This information is approved and/or reviewed by U-M Health System providers but it is not a tool for self-diagnosis or a substitute for medical treatment.albuterol, pirbuterol, and...
