Worthington Deoxyribonucleic Acid and Related Products Spectroscopy, Biochem Biophys Res Commun 55, 881, 1973 - Chang, C., and Meares, C.: Cobalt-Bleomycins and Deoxyribonucleic Acid: Sequence-Dependent Interactions, Action Spectrum for Nicking and Indifference to Oxygen, Biochem 23, 2268, 1984 - Chargaff, E., Buchowicz, J., Turler, H., and Shapiro, H.: A Direct Test of Antiparallelism in Complementary Sequences of Calf Thymus...
Drug Approvals - B Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Bacitracin Injection, 50,000 units/vial, Rx American Pharmaceutical Partners ANDA 65-116 12/3/02 - - - Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Rx Altana, Incbleomycin sulfate) Injection, USP, Rx Bristol-Myers...
1996 and Older - New Drug Application (NDA) New Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
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,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt AMOXICILLIN TRIHYDRATE 13779 01-Sep-98 BRISTOL-MYERS AMPICILLIN 13780 01-Sep-98 ACS DOBFAR SPA CEFACLOR 13781 01-Sep-98 TAIWAN BIOTECH CEPHALEXIN 13782 01-Sep-98 GIST BROCADES PENICILLIN G POTASSIUM 13783 01-Sep-98 "ZHEJIAN HISUN PHARMACEUTICAL CO., LTD." "MITOMYCIN AS MANUFACTURED IN JIAOJIANG, ZHEJIANG PROVINE, CHINA" 13784 01-Sep-98 SICOR SPA BLEOMYCIN SULFATE 13785 01...
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
Drug Approval Package FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Bleomycin Sulfate Company:-Pharmacia Application No.:-064084 Approval Date:-06/03/1996 Approval Letter(s) - Printed Labeling Chemistry Review(s) - Bioequivalence Review(s) - - Back to Drug Approval Page Some documents are in Portable Document Format (PDF) to retain the original...
ANDA Approvals October 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - October 2001 - - ANDA Number Drug Name Applicant Approval Date 1 75-839 MINOXIDIL TOPICAL SOLUTION, USP (FOR MEN) 5% (OTC) NOVEX PHARMA 10/1/01 2 75-843 OXAPROZIN TABLETS 600 MG PUREPAC PHARMACEUTICAL COSULFATE OPHTHALMIC SOLUTION, USP...
author: USERNAME
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 OfficeSulfate) Tablets SmithKline & French Laboratories 83-900 2/26/1976 12/17/2001 Benztropine Mesylate Tablets [10.9 MB] Rosemont Pharmaceutical Corp
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...
RLD_LABELING_APPROVED_OCT_1999 Reference Listed Drug Labeling Approved in October 1999 Some of the product names below contain links to the approved labeling or the supplemental approval letter describing the specific changes.- Click on the product name to view the approved labeling changes in Adobe Acrobat format
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 at 56- 57oC) 3.00 mL Antirabies Serum 3.00 mL Antitoxin (Gas Gangrene) 3.00 mL Antivenom 3.00 mL Apommorphine HCl Tablets for Injection 0.09 mg Arginine HCl Injection 500.00 mg Ascorbic Acid 4.20 mg Asparaginase for Injection 1000.00 Iu Atracurium Besylate 0.50 mg Atropine Sulfate 0.09 mg Aurothioglucose Suspension 0.70 mg Azathioprine Sodium for Injection 5.00 mg Azlocillin 75...
author: FDA / CBER
subject: December 1987 Guideline
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 page 3
author: FDA / CBER
subject: December 1987 Guideline
Cancer Care Ontario Drug Formulary Information for patients, health professionals and public on cancer prevention, screening, treatment (radiation, chemotherapy, surgery), supportive care, research, education, and standards and guidelines ...
Prescription and OTC Drug Product List 6/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 6: June 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETOHEXAMIDE BLEOMYCIN SULFATE TABLET; ORAL INJECTABLE; INJECTION ACETOHEXAMIDE BLEOMYCIN - DLT - AB BARR 500MG N70870 001 - ADD - AP GENSIA SICOR PHARMS EQ 15 UNITS BASE/VIAL...
Prescription and OTC Drug Product List 3/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 3: March 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST LIST 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 3 / JAN'2000 - MAR'2000 ACETAMINOPHEN; BUTALBITAL AMINOPHYLLINE CAPSULE; ORAL TABLET; ORAL PHRENILIN...
FDA Drug Approvals List June 2000 - Drug Approvals for June 2000 Definitions and Notes Original New Drug Applications Original Application #: 020715 Approval Date: 15-JUN-00 Trade Name:TRELSTAR DEPOT Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: DEBIO RECHERCHE PHARMACEUTIQUE SA Active Ingredient(s): TRIPTORELIN PAMOATE OTC/RX Status: RX Indication(s): For the palliative treatment of...
FDA Drug Approvals List March 2000 Original Application #: 021124 Approval Date: 17-MAR-00 Trade Name: LAMISIL Chemical Type: 6 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP Active Ingredient(s): TERBINAFINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of interdigital-type pedis (athlete’s foot), tinea cruris (jock itch)...
http://www.deltec.com/images/objects/Products/PDFs/CADDMicro/19310_Micro_Stability.pdf Drug Diluent Concentration Room Temp Refrigerated Reference Bleomycin Sulfate Sterile Water 0.5 units/ ml 24 hours (25° C) TH 5 or 1 unit/ ml Normal Saline 0.6 units/ ml 28 days* TH 2 Bupivicaine HCl Normal Saline 1.25 mg/ ml 32 days (23° C) 32 days (3° C) 6 Cytarabine Bacteriostatic 40 mg/ ml 15 days (25° C) 15 days (4° C) 2, 5 Water for...
http://www.deltec.com/images/objects/Products/PDFs/CADDMicro/19310_Micro_Stability.pdf page 2
http://www.fda.gov/cder/ogd/rld/12665s39.PDF page 6
FDA Drug Approvals List October 1999 Application #: 020156 Efficacy Supplement#: 022 Type: SE2 to Original New Drug Application Approval Date: 28-OCT-99 Trade Name: VIDEX Dosage Form: POWDER, FOR RECONSTITUTION Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): DIDANOSINE OTC/RX Status: RX Efficacy Claim:Provides for a new strength as well as allowing a change in dosing interval...
FDA Drug Approvals List August 1999 Approvable Original New Drug Applications Original Application #: 021037 Approvable Date: 26-AUG-99 Trade Name: MAGNEVIST Dosage Form: INJECTABLE Applicant: BERLEX LABORATORIES INC Active Ingredient(s): GADOPENTETATE DIMEGLUMINE OTC/RX Status: RX Original Application #: 020989 Approvable Date: 27-AUG-99 Trade Name: EVOXAC Dosage Form: CAPSULE Applicant: SNOWBRAND PHARMACEUTICALS INC...
DDPA June 1996 50-719 HELIDAC KIT PROCTOR GAMBLE PHARM BISMUTH SUBSALICYLATE 05-JUN-96 (TABLET, CHEWABLE; CINCINNATI, OH 262.4MG/TABLET CHEWABLE TABLET; 45241 METRONIDAZOLE CAPSULE) 250MG/TABLET TETRACYCLINE 500MG/CAPSULE (ANTIULCER) 20-593 DEPACON ABBOTT VALPROATE SODIUM 06-JUN-96 (INJECTABLE) ABBOTT PARK, IL EQ 100MG ACID/ML 60064 (ANTICONVULSANT) 20-441 PULMICORT-200 ASTRA BUDESONIDE 14-JUN-96 ...
DDPA February 1996 IT IS USEFUL IN THE DELINEATION OF REGIONS OF REVERSIBLE MYOCARDIAL ISCHEMIA IN THE PRESENCE OR ABSENCE OF INFARCTED MYOCARDIUM] 11-522 ADDERALL 10 RICHWOOD PHARM AMPHETAMINE ASPARTATE 13-FEB-96 (TABLET) FLORENCE, KY 2.5MG (SUPPL-010) 41042 AMPHETAMINE SULFATE 2.5MG DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE 2.5MG (AMPHETAMINE) 11-522 ADDERALL 20 RICHWOOD...
