What's new at CDER by Date - U.S
author: Paul Stauffer
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, IncCleocin HCl ® ...
author: Judit Milstein
E:\cleocin labels\Antibact resist AP.doc page 1
author: Judit Milstein
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...
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
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
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...
author: Paul Stauffer
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...
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 #:...
Prescription and OTC Drug Product List 1/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA KV PHARM 500MG/15ML;7.5MG/15ML N40366 001 JAN 23, 2002 JAN NEWA AMPHOTERICIN B INJECTABLE, LI COMPLEX; INJECTION ABELCET -A- + ELAN PHARMS 5MG/ML N50724 001 NOV 20, 1995 JAN CAHN -D- + LIPOSOME 5MG/ML N50724 001 NOV 20, 1995 JAN...
http://www.fda.gov/cder/foi/label/2001/50441s47lbl.pdf 816 287 304A NDC 0009-0870-26 300 mg/2 mL Contains 25 of NDC 0009-0870-21 6505-01-185-3309 25N 2 mL Single Dose Vials Equivalent to 300 mg clindamycin For intramuscular or intravenous use clindamycin injection, USP Cleocin Phosphate ® N D C 0 0 0 9 0 8 7 0 2 6 300 mg/2 mL C o n t a i n s 2 5 o f N D C 0 0 0 9 0 8 7 0 2 1 6 5 0 5 0 1 1 8 5 3 3 0 9 2 5 N 2...
author: CDER USER
http://www.fda.gov/cder/foi/label/2001/50441s47lbl.pdf page 6
author: CDER USER
http://www.fda.gov/cder/foi/label/2001/50441s47lbl.pdf page 5
author: CDER USER
http://www.fda.gov/cder/foi/label/2001/50441s47lbl.pdf page 4
author: CDER USER
http://www.fda.gov/cder/foi/label/2001/50441s47lbl.pdf page 3
author: CDER USER
http://www.fda.gov/cder/foi/label/2001/50441s47lbl.pdf page 2
author: CDER USER
http://www.fda.gov/cder/foi/label/2001/50441s47lbl.pdf page 1
author: CDER USER
Carek org/ afp VOLUME 63, NUMBER 12 / JUNE 15, 2001 TABLE 7 Initial Antibiotic Regimens for Patients with Osteomyelitis Organism Antibiotic( s) of first choice Alternative antibiotics Staphylococcus aureus or coagulase- Nafcillin (Unipen), 2 g IV every 6 hours, or First- generation cephalosporin or vancomycin negative (methicillin- sensitive) clindamycin phosphate (Cleocin ...
Carek page 6
http://www.fda.gov/cder/foi/appletter/2001/50441s47ltr.pdf NDA 50- 441/ S- 047 Pharmacia & Upjohn Company 21 NOV 2001 Attention: Rebecca Tong, MS 7000 Portage Road Kalamazoo, MI 49001- 0199 Dear MsCleocin Phosphate (clindamycin ...
http://www.fda.gov/cder/foi/appletter/2001/50441s47ltr.pdf page 1
Prescription and OTC Drug Product List 10/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 10: October 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE BENZYL PENICILLOYL-POLYLYSINE CAPSULE; ORAL INJECTABLE; INJECTION BUTALBITAL, ACETAMINOPHEN AND CAFFEINE PRE-PEN - ADD - AB WEST WARD 500MG;50MG;40MG N40261...
Prescription and OTC Drug Product List 8/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 8: August 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AZATHIOPRINE SODIUM CAPSULE; ORAL INJECTABLE; INJECTION FEMCET IMURAN - DLT - AB MALLINCKRODT 325MG;50MG;40MG N89102 001 - ADD - AP + FARO PHARMS EQ 100MG BASE...
Prescription and OTC Drug Product List 1/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 1: January 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST PRESCRIPTION DRUG PRODUCT LIST 1 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'2000 - ADD - CALCIUM CHLORIDE CEFTIBUTEN DIHYDRATE - ADD -...
Prescription and OTC Drug Product List 2/2001 PEDIATRIC - ADD - @ 10MG;100MG N74080 001 - ADD - + ASTRAZENECA /1VIL;0.02MG/VIAL;0.001MG/VIAL; - ADD - MAR 25, 1994 - ADD - 5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL; - ADD - @ 25MG;100MG N74080 002 - ADD - 17MG/VIAL;0.2MG/VIAL; - ADD - MAR 25, 1994 - ADD - EQ 1MG BASE/VIAL;1.4MG/VIAL; - ADD - @ 25MG;250MG N74080 003 - ADD - EQ 1.2MG BASE/VIAL;0.7MG/VIAL; - ADD - MAR 25, 1994 - ADD - 7MG...
