http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W/ CODEINE, CODEINE...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt DIAZEPAM 1516 23-Apr-70 AVENTIS PHARMA SA CHLORPROMAZINE HYDROCHLORIDE 1534 01-Jun-70 PHARMACIA AND UPJOHN INC CYTARABINE AS MANUFACTURED IN KALAMAZOO MI 1535 11-Jun-70 PHARMACIA AND UPJOHN INC MEDRYSONE 1541 25-Jun-70 PHARMACIA AND UPJOHN INC FLUOROMETHOLONE MICRONIZED 1581 21-Sep-70 AVENTIS PHARMA SA CROMOLYN SODIUM AND CROMOLYN SODIUM/LACTOSE BLEND 1631 05-Jan-71 ADAMHA NIMH DELTA...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls DIAZEPAM AVENTIS PHARMA SA CHLORPROMAZINE HYDROCHLORIDE PHARMACIA AND UPJOHN INC CYTARABINE AS MANUFACTURED IN KALAMAZOO MI PHARMACIA AND UPJOHN INC MEDRYSONE PHARMACIA AND UPJOHN INC FLUOROMETHOLONE MICRONIZED AVENTIS PHARMA SA CROMOLYN SODIUM AND CROMOLYN SODIUM/LACTOSE BLEND ADAMHA NIMH DELTA-9-TRANS-TETRAHYDROCANNABINOL-DELTA-9-TRANS-TETRAHYDROCANNABINOL SSL INTERNATIONAL...
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
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, 2003 APR...
author: AUTHOR
Availability and Use of Parenteral Quinidine Gluconate for Severe or Complicated Malaria Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Availability and Use of Parenteral Quinidine Gluconate for Severe or Complicated Malaria Since 1991, quinidine gluconate, a class Ia anti-arrhythmic agent, has been the only parenteral antimalarial available for use in the United States (1)
author: Meyerhoff
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;30MG N40441 001...
author: AUTHOR
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_JUN_1998.HTML Reference Listed Drug Labeling Approved in June 1998 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
rld_labeling_approved_june_1999 Firm Date HIVID Zalcitabine tablets 20-199 S-013 Roche 01-Jun-1999 PROVENTIL-HFA Albuterol sulfate inhalation aerosol 20-503 S-011 3M Pharmaceuticals 02-Jun-1999 CRIXIVAN Indivir sulfate capsules 20-685 S-023 et al Merck Research 04-Jun-1999 VERALAN PM Verapamil HCl extended-release capsules 20-493 S-002 Elan Pharmaceutical 04-Jun-1999 DOPAMINE Dopamine HCl in 5% dextrose injection...
Prescription and OTC Drug Product List 12/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL SYNALGOS-DC-A -A- @ WOMEN FIRST HLTHCARE 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN -D- @ WYETH AYERST 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL ANEXSIA 5/325 -D- AA MALLINCKRODT 325MG;5MG N40409...
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 12.00 mg 14.30 mg 0.28 mg 1.43 mg 2.80 mg 1.00 mg 0.43 mg 1.10 mg Propoxycaine, Procaine HCI & Levonordefrin 6.60 mg Propoxycaine, Procaine HCI & Norepinephrine Bitartrate 6.60 mg 49 0.50 100.00 # 4.55 0.003 0.03/ 100 units 17.00 + 8.80 + 8.80 + 0.50 + 1.10 + 0.50 0.50 0.10 + 31.25 4.39 5.00 5.80 + 8.80 + 0.90 + 0.90 + 0.60 + 0.60 + 0.60 + 0.60 + 0.42 0.35 + 17.90 + 3.50 1.80 + 5.00 ...
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 6
author: FDA / CBER
subject: December 1987 Guideline
Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 30
author: FDA
Quarterly List of Guidance Documents at the Food and Drug Administration page 13
author: FDA
Prescription and OTC Drug Product List 9/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 9: September 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE - ADD - ARSENIC TRIOXIDE TABLET; ORAL - ADD - INJECTABLE; INJECTION HYDROCODONE BITARTRATE AND ACETAMINOPHEN - ADD - TRISENOX - ADD - AA MALLINCKRODT 325MG...
SUPAC Chair, CMC CC Appendix A Narrow Therapeutic Range Drugs Aminophylline Tablets, ER Tablets Carbamazepine Tablets, Oral Suspension Clindamycin Hydrochloride Capsules Clonidine Hydrochloride Tablets Clonidine Transdermal Patches Dyphylline Tablets Disopyramide Phosphate Capsules, ER Capsules Ethinyl Estradiol/Progestin Oral Contraceptive Tablets Guanethidine Sulfate Tablets Isoetharine...
http://www.fda.gov/cber/gdlns/guidelst.txt Drug Advertising and Promotional Labeling DDMAC 2 Dissemination of Reprints of Certain October 8, 1996 Advertising Do Published, Original Data Funded Dissemination of Reference October 8, 1996 Do Do Texts Antifungal (topical) February 24, 1990 Biopharmaceutic Drug Information Branch (Draft) Antifungal (vaginal) February 24, 1990 Do Do Food-Effect Bioavailability and December 30, 1997...
FDA Drug Approvals List- June 1999 ROBINS COMPANY Active Ingredient(s): ISOSORBIDE MONONITRATE OTC/RX Status: RX Application #: 018074 Labeling Supplement#: 029 To Original New Drug Application Approval Date: 16-JUN-99 Trade Name: PHENDIMETRAZINE TARTRATE Dosage Form: CAPSULE, EXTENDED RELEASE Applicant: EON LABORATORIES Active Ingredient(s): PHENDIMETRAZINE TARTRATE OTC/RX Status: RX Application #: 012940 Labeling...
FDA Drug Approvals List- July 1998 Drug Approvals for July 1998 Definitions and Notes July 1998 Original New Drug Applications Original Application #: 020822 Approval Date: 17-JUL-98 Trade Name: CELEXA Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: FOREST LABORATORIES INC Active Ingredient(s): CITALOPRAM HYDROBROMIDE OTC/RX Status: RX Indication(s): TREATMENT OF DEPRESSION Original...
FDA Drug Approvals List- June 1998 Drug Approvals for June 1998 Definitions and Notes June 1998 Original New Drug Applications Original Application #: 020865 Approval Date: 29-JUN-98 Trade Name: MAXALT - MLTRA ISC Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC Active Ingredient(s): RIZATRIPTAN BENZOATE OTC/RX Status: RX Indication(s): Acute...
DDPA August 1995 74-462 CAPTOPRIL COPLEY PHARMA CAPTOPRIL 24-AUG-95 (TABLET) CANTON, MA 12.5MG 02021 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) 74-505 CAPTOPRIL WESTWARD CAPTOPRIL 31-AUG-95 (TABLET) EATONTOWN, NJ 12.5MG 07724 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 19-766 ZOCOR MERCK SIMVASTATIN 01-AUG-95 (TABLET) WEST POINT...
DDPA July 1995 74-477 CAPTOPRIL HALLMARK PHARMA CAPTOPRIL 31-JUL-95 (TABLET) SOMERSET, NJ 12.5MG 08873 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-087 ETHRANE OHMEDA ENFLURANE 05-JUL-95 (LIQUID) LIBERTY CORNER, NJ 99.9% 07938 (LABELING REVISION -- PRECAUTIONS) 17-624 FORANE OHMEDA ISOFLURANE 05-JUL-95 (LIQUID) LIBERTY CORNER, NJ 99.9%...
C:\WPFILES\GUIDANCE\CHEMISTR\CMC5. Chair, CMC CC A- 1 Appendix A Narrow Therapeutic Range Drugs Aminophylline Tablets, ER Tablets Carbamazepine Tablets, Oral Suspension Clindamycin Hydrochloride Capsules Clonidine Hydrochloride Tablets Clonidine Transdermal Patches Dyphylline Tablets Disopyramide Phosphate Capsules, ER Capsules Ethinyl Estradiol/ Progestin Oral Contraceptive Tablets Guanethidine Sulfate Tablets...
author: CDER User
C:\WPFILES\GUIDANCE\CHEMISTR\CMC5. page 30
author: CDER User
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