Professional Standards Directorate Fact Sheet: Two page 15
author: Jo Raffaitin
Product Listing - Endo Pharmaceuticals Pain Management Products Frova® (frovatriptan succinate) tablets View package insert PDF DepoDur ® (morphine sulfate extended-release liposome injection) View package insert PDF Lidoderm ® patch View package insert PDF Narcan ® injectable View package insert PDF Nubain ® injectable View package insert PDF Numorphan ® injectable & suppository CII View package...
All Products - Endo Pharmaceuticals Pain Management Products Frova® (frovatriptan succinate) tablets View package insert PDF DepoDur ® (morphine sulfate extended-release liposome injection) View package insert PDF Lidoderm ® patch View package insert PDF Narcan ® injectable View package insert PDF Nubain ® injectable View package insert PDF Numorphan ® injectable & suppository CII View package...
All Products - Endo Pharmaceuticals Pain Management Products Frova® (frovatriptan succinate) tablets View package insert PDF DepoDur ® (morphine sulfate extended-release liposome injection) View package insert PDF Lidoderm ® patch View package insert PDF Narcan ® injectable View package insert PDF Nubain ® injectable View package insert PDF Numorphan ® injectable & suppository CII View package...
http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt "HOMATROPINE HYDROBROMIDE, MANUFACTURED IN INGELHIEM/RHEIN, GERMANY" 12068 31-Jul-96 MULTIPLE PEPTIDE SYSTEMS "P-113 SYNTHETIC PEPTIDE, MANUFACTURED IN SAN DIEGO, CA" 12072 05-Aug-96 LIANYUNGANG PHARMACEUTICAL FACTORY "MESNA, MANUFACTURED IN JIANGSU PROVINCE, PEOPLE'S REPUBLIC OF CHINA" 12074 06-Aug-96 PTI ADVANCED FILTRATION INC "PROFLOW II, MANUFACTURED IN NEWBURY, CALIFORNIA"...
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004 - TABLET; DELAYED RELEASE; ORAL Denied 9/16/1999- HYDROMORPHONE HYDROCHLORIDE 0.2 MG/ML - 30 ML - 98P-0821/CP1 ABBOTT LABORATORIES - INJECTABLE; INJECTION Denied 9/29/1999- CYCLOSPORINE 25 MG; 50 MG; 100 MG - 98P-0858/CP1 APOTEX CORP - TABLET; ORAL Approved 9/16/1999- METHYLPREDNISOLONE 4 MG & 16 MG - 98P-0911/CP1 RICHARD HAMER ASSOCIATES, INC
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004 - SUSPENSION; TOPICAL Pending - HYDROMORPHONE HYDROCHLORIDE 0.2 MG/ML - 30 ML - 98P-0821/CP1 ABBOTT LABORATORIES - INJECTABLE; INJECTION Denied 9/29/1999- HYDROQUINONE 4% TRETINOIN 0.01% - 03P-0365/CP1 JERUSSI CONSULTING - TOPICAL SOLUTION Denied - IBUPROFEN 200 MG - 99P-0683/CP1 FPC CONSULTING INCHYDROCHLORIDE 1 MG -...
Paddock Laboratories, Inc. - Other RX's BACITRACIN USP STERILE BELLADONNA & OPIUM SUPPOSITORIES COLISTIN SULFATE USP POWDER COLOCORT® Hydrocortisone Rectal Suspension, USP (Retention) COMPRO™ Prochlorperazine Suppositories, USP 25mg DEXAMETHASONE SODIUM PHOSPHATE USP POWDER HYDROCORTISONE ACETATE USP MICRONIZED POWDER HYDROCORTISONE ACETATE SUPPOSITORIES (Hemorrhoidal HC Suppositories) HYDROCORTISONE USP...
Paddock Laboratories, Inc. - Master Product List USP (Enteric-Coated Yellow) OTC 0004-01 0004-10 0004-11 5 mg - 100's 5 mg - 1000's 5 mg - U/D 100's - - - [C]--PRODUCTS-- Rx or OTC NDC 0574- Strength / Size MSDS Secundum Artem Issues Biblio- graphy Listing CASTOR OIL USP OTC 3312-02 2 oz Vol 3 No 4 ; Vol 5 No 3 ; Vol 10 No 2 - COLISTIN SULFATE USP POWDER Rx 0417-01 1 BU ** - - COLLODION, FLEXIBLE USP OTC 0560-04 4 oz - - - COLOCORT...
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,...
author: AUTHOR
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
Hydromorphone 6392-03.qxd page 1
author: ian oldham
hmhcl page 3
hmhcl page 1
HMORSUPP.PDF page 2
Paddock Laboratories, Inc. - Suppositories ASPIRIN SUPPOSITORIES USP BELLADONNA & OPIUM SUPPOSITORIES BISACODYL SUPPOSITORIES USP COMPRO™ Prochlorperazine Suppositories, USP 25mg ENCORT™ (Hydrocortisone Acetate Suppositories) 30mg HYDROCORTISONE ACETATE SUPPOSITORIES (Hemorrhoidal HC Suppositories) HYDROMORPHONE HCL SUPPOSITORIES MORPHINE SULFATE SUPPOSITORIES PHENADOZ (Promethazine HCl Suppositories USP)...
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...
FDA Drug Approvals List July 2001 PERRIGO COMPANY Active Ingredient(s):ACETAMINOPHEN; ASPIRIN;CAFFEINE OTC/RX Status: RX Labeling Supplements to Original New Drug Applications Application #: 019906 Labeling Supplement#: 009 To Original New Drug Application Approval Date: 31-JUL-01 Trade Name: ANAFRANIL Dosage Form: CAPSULE Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE ...
2003 Export Products List Alphabetical ORDER # pms- PRODU TS FORMAT OMPARABLE TO LASSIFI ATION ( System): INDI ATIONS PRODU TS AVAILABLE FOR EXPORT Effe tive: July 2003 LISTINGS IN RED ARE C NTR LLED DRUGS Page: 9 pms- holestyramine - pms- o aine Powder 5760633300 N Covan Syrup 100 mL C0- Actifed Syrup Cough Syrup (Codeine Phosphate, Triprolidine Hydrochloride, 5760633301 N Covan Syrup 500 mL Pseudoephedrine ...
author: Lee S. Ehler
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices Conc.( equine) 3.00 mL Dipyridamole 0.14 mg Dobutamine HCI 0.90 mg 5.00 1.10 2.17 3.57 1.80 1.80 1.80 1.80 45.45 5.00 1.25 5.56 11.60 + 0.50 + 35.70 + 71.43 16.70 + 17.20 + 0.70 + 0.70 + 111.00 + 200.00 + 1.00 357.00 0.003 + 0.50 + 166.67 1.00 4.00 0.50 + 1.00 8.77 3.40 + 16.67 1.67 37.70 5.56 40 Dopamine HCI Dopamine HCl in Dextrose Doxapram HCI Injection Doxorubicin HCI for...
author: FDA / CBER
subject: December 1987 Guideline
http://www.medvet.com.au/downloads/drg_scr/sitescreen_product_insert.pdf M e t h a d o n e: Methadone is a synthetic analgesic drug that is originally used in the treatment of narcotic addicts. Among the psychological effects induced by using methadone are analgesia, sedation and respiratory depression. Overdose of methadone may cause coma or even death. It is administered ...
http://www.medvet.com.au/downloads/drg_scr/sitescreen_product_insert.pdf page 2 PERFORMANCE CHARACTERISTICS A. Accuracy For each individual drug screen assay, approximately 60 urine samples of specific drugs were obtained form clinical laboratories. The concentration of drug present in the samples was determined by either GC/ MS or commercial kits. Each sample was then ...
Prescription and OTC Drug Product List 7/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 7: July 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE - ADD - CALFACTANT TABLET; ORAL - ADD - INJECTABLE; INJECTION BUTALBITAL,ACETAMINOPHEN AND CAFFEINE - ADD - INFASURF PRESERVATIVE FREE - ADD - AB + MIKART 500MG...
http://www.deltec.com/images/objects/Products/PDFs/CADDMicro/19310_Micro_Stability.pdf Drug Stability Data for CADD- Micro ® Micro Medication Reservoir Reference Guide IMPORTANT NOTE: The compilation of data included in this reference guide has been prepared solely for the purpose of acquainting clinicians with the stability of selected drugs for use with the CADD- Micro ® infusion pump
