|
|
|
|
http://www.fda.gov/cder/orange/appendix_a.txt
400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE EC-NAPROSYN, NAPROXEN ECONAZOLE NITRATE, ECONAZOLE NITRATE ECONOCHLOR, CHLORAMPHENICOL ECONOPRED PLUS, PREDNISOLONE ACETATE ECONOPRED, PREDNISOLONE ACETATE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID EDETATE DISODIUM, EDETATE DISODIUM EDEX, ALPROSTADIL EDROPHONIUM CHLORIDE PRESERVATIVE FREE, EDROPHONIUM...
|
|
|
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
"DIHYDROERGOTAMINE MESYLATE MANUFACTURED IN INGELHEIM, GERMANY" 10247 17-May-93 DIOSYNTH BV "PANCURONIUM BROMIDE MANUFACTURED IN OSS, THE NETHERLANDS" 10253 12-May-93 NEULAND LABORATORIES LTD "ALBUTEROL BASE MANUFACTURED IN BONTHAPALLI VILLIAGE, JINNARAM MANDAL, ANDHRA PRADESH, INDIA" 10262 25-May-93 JETPHARMA SA "CONTRACT MICRONIZATION SERVICES LOCATED IN BALERNA,...
|
|
|
Prescription and Over-the-Counter Drug Product List: 6/2003
>D> AT ALLERGAN 1% N61187 001 JUN DISC >A> @ 1% N61187 001 JUN DISC >D> SOLUTION/DROPS; OPHTHALMIC >D> CHLOROPTIC >D> + ALLERGAN 0.5% N50091 001 JUN DISC >A> @ 0.5% N50091 001 JUN DISC >D> CHLOROQUINE HYDROCHLORIDE >D> INJECTABLE; INJECTION >D> ARALEN HCL >D> + SANOFI SYNTHELABO EQ 40MG BASE/ML N06002 002 JUN DISC >A> @ EQ 40MG BASE/ML N06002 002 JUN DISC CHLORPROMAZINE ...
author: AUTHOR
|
|
|
Prescription and OTC Drug Product List 6/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA PEACHTREE 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN -A- AA UCB 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL DARVOCET -A- @ AAIPHARMA LLC 325MG;32.5MG N16844 001 JUN CAHN ...
|
|
|
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
Dexamethasone Acetate Suspension Dexamethasone Sodium Phosphate Dexpanthenol Dextran 40 Dextran 40 in Sodium Chloride Dextran 70 Dextrose < 5% Dextrose- 5%- 70% Dextrose and Sodium Chloride Dezocine 0.03 mg 166.70 + 2.50 mg 2.00 + 0.36 mg 13.89 1.60 units 3.10 + 5.00 mg 1.00 3.57 mcg 1.40 1.86 CSR units 2.69 0.02 ing 0.02 mg 14.30 mcg 1.00 mg 30.00 mg 0.12 mL 7.14 mg 3.00 mg 1.93 mg...
author: FDA / CBER
subject: December 1987 Guideline
|
|
|
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004
- - Pending - CYCLOBENZAPRINE HYDROCHLORIDE 7.5 MG - 03P-0461/CP1 ANABOLIC LABORATORIES - - Pending 10/1/2003- CLONAZEPAM 1 MG/5 ML - 03P-0464/CP1 LACHMAN CONSULTANT SERVICES - ORAL SOLUTION Pending 10/2/2003- HYDROCODONE BITARTRATE 5 MG ACETAMINOPHEN 325 MG - 03P-0475/CP1 INT'L REGULATORY BUSINESS CONS - LIQUID; ORAL Pending - ACETAMINOPHEN 770 MG, 385 MG CAFFEINE 60 MG, 30 MG...
|
|
|
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004
- SOLUTION; ORAL Withdrawn 12/20/2001- DIGOXI N 0.25 MG/5 ML - 02P-0503/CP1 ROXANE LABORATORIES - ELIXIR Withdrawn - DIHYDROERGOTAMINE MESYLATE 2 MG/ML - 03P-0556/CP1 HYMAN, PHELPS & MCNAMARA - INJECTION Pending - DILTIAZEM HYDROCHLORIDE 125MG/5ML;250MG/10ML - 98P-0189/CP1 BEDFORD LABORATORIES - INJECTION Withdrawn - DIVALPROEX SODIUM 1000 MG - 03P-0178/CP1 LACHMAN...
|
|
|
SSCI Inc.: X-ray Powder Diffraction, Raman and Infrared Spectroscopy, Differential Scanning Calorimetry, and Thermogravimetric
Phone: 800 375-2179 / 765 463-0112 Fax: 765 497-2649 / 765 463-4722 E-mail: info@ssci-inc.com SSCI Inc., 3065 Kent Avenue, West Lafayette, IN 47906 - 1076 USA Acetaminophen Acetazolamide Acetohexamide Acetylcysteine Acyclovir Adenine L-Alanine Albuterol Albuterol Sulfate Allopurinol Alprazolam Amantadine HCl Amiloride HCl Aminobenzoic Acid Aminoglutethimide Aminosalicylic Acid...
author: SSCI Webmaster
|
|
|
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 6
author: FDA / CBER
subject: December 1987 Guideline
|
|
|
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
MALLINCKRODT INC GALLIUM CHL GA-67--MFGR AT MARYLAND HGTS., MISSOURI CYCLOTRON FACILITY PERKINELMER LIFE SCIENCES INDIUM-111 PRODUCED IN NORTH BILLERICA, MASS FACILITIES SOCIETA ITALIANA MEDICINALI SCANDICCI (SIMS) LIDOCAINE BASE CRYSTALLIZED & LIDOCAINE HcL MAY AND BAKER LTD ACEBUTOLOL HCL/SECTRAL SOCIETA ITALIANA CORTICOSTEROIDI SPA BETAMETHASONE DIPROPIONATE SCHERING...
|
|
|
Prescription and Over-the-Counter Drug Product List: 5/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
|
|
|
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...
|
|
|
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...
|
