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...
1997 Abbreviated New Drug Applications (Generic Drugs) Generic Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information OfficePhosphate Purepac Pharmaceutical 086683 -05/11/1979 8/4/2003 Acetaminophen-Codeine Phosphate Purepac Pharmaceutical 086681 -05/11/1979 8/4/2003 Acetazolamide Tablets...
Drug Approvals September 1996 CATARRHALIS TO THE INDICATIONS AND USAGE SECTION Approvable Original New Drug Applications Original Application #: 020535 Approvable Date: 30-SEP-96 Trade Name: DURACT Dosage Form: CAPSULE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): BROMFENAC SODIUM OTC/RX Status: RX Original Application #: 020690 Approvable Date: 19-SEP-96 Trade Name: ARICEPT Dosage Form: TABLET...
Drug Approvals - D ANDA 74-904 7/14/98 7/14/98 - 3/16/99 Desoxyn (methamphetamine HCl) Tablets and Desoxyn (methamphetamine HCl) Gradumet Tablets, 5 mg & 5 mg, 10 mg, and 15 mg, Rx- Abbott Laboratories NDA 5-378/S-020 12/6/01 4/3/03 Detrol LA Extended- Release Capsules, Rx Pharmacia and Upjohn NDA 21-228 /S5 1/15 /04 1/22/04 - Detrol LA Extended- Release Capsules, Rx Pharmacia and Upjohn NDA 21-228 /S4...
What's new at CDER by Date - U.S
author: Paul Stauffer
FACT SHEET Stability Time for Maxipime Admixture and IV Infusion RT/ L Refrigeration Concentration Concentration Solutions (20°TH 25° C) (2°TH 8° C) 40 mg/ mL Amikacin NS or D5W 24 hours 7 days 6 mg/ mL 40 mg/ mL Ampicillin D5W 8 hours 8 hours 1 mg/ mL 40 mg/ mL Ampicillin D5W 2 hours 8 hours 10 mg/ mL 40 mg/ mL Ampicillin NS 24 hours 48 hours 1 mg/ mL 40 mg/ mL Ampicillin...
author: K. Notarianni
FACT SHEET page 6
author: K. Notarianni
duplicates:http://www.elan.com/Images/Maxipime_PI_200204_tcm3-4348.pdf
MAX0173 Full PI-4 pager Stability Time for Maxipime Admixture and IV Infusion RT/ L Refrigeration Concentration Concentration Solutions (20°TH 25° C) (2°TH 8° C) 40 mg/ mL Amikacin NS or D5W 24 hours 7 days 6 mg/ mL 40 mg/ mL Ampicillin D5W 8 hours 8 hours 1 mg/ mL 40 mg/ mL Ampicillin D5W 2 hours 8 hours 10 mg/ mL 40 mg/ mL Ampicillin NS 24 hours 48 hours 1 mg/ mL 40 mg/ mL Ampicillin...
author: Freelance
CDER Guidance Documents (Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [ PDF ] M4 Common Technical Document--Quality: Questions and Answers/Location Issues [ HTML ] or [ PDF ] or [ ] (Issued 9/12/2002, Posted 12/30/2002) Quality Q1E Evaluation of...
Sep Xs 16-3D.qxd Separation of Lincomycin and Clindamycin - Scaling Up to Short Analytical Column Using Volatile Mobile Phase Column: ZORBAX StableBond C18 4.6 x 50 mm, 5 µm Part Number: 846975- 902 Mobile Phase: Gradient: 0 to 40% B in 5 min Detection: UV 210 nm A: Water w/ 0.2% Formic Acid B: ACN w/ 0.2% Formic Acid Flow Rate: 1.0 mL/ min Injection Volume: 10 µL Temperature: Ambient...
author: j
E:\cleocin labels\Antibact resist AP.doc DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 50- 162/ S- 084 NDA 50- 441/ S- 048 NDA 50- 639/ S- 014 Pharmacia and Upjohn Company A subsidiary of Pfizer, Inc
author: Judit Milstein
E:\cleocin labels\Antibact resist AP.doc page 1
author: Judit Milstein
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt OF IRELAND" 13266 05-Oct-98 FABBRICA ITALIANA SINTETICI SPA "NITROFURANTOIN MONHYDRATE, MANUFACTURED IN VICENZA, ITALY" 13277 22-Oct-98 MATRIX LABORATORIES LIMITED "ACYCLOVIR USP, MANUFACTURED IN ANDHRA PRADESH, INDIA" 13279 19-Oct-98 SYLACHIM DIV FINORGA "LEVOBETAXOLOL HYDROCHLORIDE, MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE" 13282 15-Oct-98 DAICEL CHEMICAL INDUSTRIES LTD "CHIRALPAK...
Reference Listed Drug Labeling Approved in November 2001 Nov 1 COREG letter ---- carvedilol tablets 20-297 S-007 INDERIDE LA letter label propranolol HCl/HCTZ extended-release capsules 19-059 S-016 INDERIDE letter label propranolol HCl/HCTZ tablets 18-031 S-030 Nov 5 TAMIFLU letter label oseltamivir phosphate suspension oseltamivir phosphate capsules 21-246 21-087 S-004 S-009 Nov 7 REGLAN letter label metoclopramide HCl solution...
author: USERNAME
Prescription and Over-the-Counter Drug Product List: 8/2003 4 >D> AA + ORTHO MCNEIL PHARM 300MG;60MG N85055 004 AUG DISC >A> @ 300MG;60MG N85055 004 AUG DISC ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA + MALLINCKRODT 500MG/15ML;10MG/15ML N40508 001 AUG 29, 2003 AUG NEWA >D> MIKART 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG CTEC >A> AA 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG...
author: AUTHOR
ANDAs Approvals - May 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals May 2000 - 1
author: USERNAME
First-Time Generics - January 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - January 2002 Generic Name Brand Name Approval Date 1 SULFASALAZINE DELAYED-RELEASE TABLETS, USP 500 MG AZULFIDINE EN-TABS 1/11/02 2 OFLOXACIN INJECTION 40 MG/ML (10 ML SINGLE-DOSE VIALS) FLOXIN I.V
author: USERNAME
65-027_Clindamycin Phosphate Dextrose Injection Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Clindamycin Phosphate Company:--Abbott Laboratories Application No.:--65-027 Approval Date:-6/29/2001 - Approval Letter(s) - Printed Labeling - Chemistry Review(s) - Microbiology Review(s) - Bioequivalence Review(s) - Administrative Document(s) - Correspondence - - Back to...
author: Paul Stauffer
50767_Cleocin.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Cleocin (Clindamycin Phosphate) Vaginal Ovules Company:- Pharmacia & Upjohn Application No.:- 50-767 Approval Date:-8/13/1999 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Part 1 - Part 2 - Chemistry Review(s) - Pharmacology Review(s) - Statistical Review(s)...
author: Paul Stauffer
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 insulin
author: Brenda Harmon
Prescription and Over-the-Counter Drug Product List: 3/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG...
author: AUTHOR
Osteomyelitis Treatment TABLE 7 Initial Antibiotic Regimens for Patients with Osteomyelitis Organism Antibiotic(s) of first choice Alternative antibiotics Staphylococcus aureus or coagulase-negative (methicillin-sensitive) staphylococci - Nafcillin (Unipen), 2 g IV every 6 hours, or clindamycin phosphate (Cleocin Phosphate), 900 mg IV every 8 hours - -First-generation cephalosporin or vancomycin...
FDA Drug Approvals List February 2001 Approvable Original New Drug Applications - Original Abbreviated New Drug Applications Original Abbreviated Application # 075402 Approval Date: 28-FEB-01 Trade Name: METAPROTERENOL SULFATE Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): METAPROTERENOL SULFATE OTC/RX Status: RX Original Abbreviated Application # 075403 Approval Date: 28-FEB-01 Trade Name:...
FDA Drug Approvals List July 2002 45 Dosage Form: INJECTABLE Applicant: XCEL PHARMACEUTICALS Active Ingredient(s): DIHYDROERGOTAMINE MESYLATE OTC/RX Status: RX Application #: 020449 Labeling Supplement #: 019 To Original New Drug Application Approval Date: 30-JUL-02 Trade Name: TAXOTERE Dosage Form: INJECTABLE Applicant: AVENTIS PHARMACEUTICALS INC Active Ingredient(s): DOCETAXEL OTC/RX Status: RX Application #:...
FDA Drug Approvals List January 2002 - Drug Approvals for January 2002 Definitions and Notes Original New Drug Applications Efficacy Supplemental New Drug Applications Application #: 020837 Efficacy Supplement #: 006 Type: SE5 to Original New Drug Application Approval Date: 30-JAN-02 Trade Name: XOPENEX Dosage Form: SOLUTION Applicant: SEPRACOR, INC Active Ingredient(s): LEVALBUTEROL HYDROCHLORIDE OTC/RX Status: RX...
