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...
Prescription and Over-the-Counter Drug Product List: 6/2003 4 >D> + ROBINS AH 325MG;60MG N84446 001 JUN DISC >A> @ 325MG;60MG N84446 001 JUN DISC ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE; ORAL DIAMOX >A> @ DURAMED PHARM BARR 500MG N12945 001 JUN CAHN >A> + 500MG N12945 003 APR 25, 1995 JUN CAHN >D> @ LEDERLE 500MG N12945 001 JUN CAHN >D> + 500MG N12945 003 APR 25, 1995 JUN CAHN TABLET; ORAL >A> AB DURAMED PHARM BARR 125MG N08943 001 JUN CAHN ...
author: AUTHOR
FDA Drug Approvals List February 2002 Active Ingredient(s): BUSPIRONE HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application#065022 Approval Date: 27-FEB-02 Trade Name: BACITRACIN ZINC AND POLYMYXIN B SULFATE Dosage Form: OINTMENT Applicant: ALTANA INC Active Ingredient(s): BACITRACIN ZINC; POLYMYXIN B SULFATE OTC/RX Status: RX Original Abbreviated Application# 075874 Approval Date: 26-FEB-02 Trade...
http://www.fda.gov/cder/foi/label/2002/20793slr003lbl.pdf Dose of CAFCIT Dose of CAFCIT (caffeine citrate) (caffeine citrate) Route Frequency Volume mg/ kg Loading Dose 1 mL/ kg 20 mg/ kg Intravenous* One Time (over 30 minutes) Maintenance eswe0.25 mL/ kg 5 mg/ kg Intravenous* Every 24 Dose (over 10 hours** minutes) or Orally * using a syringe infusion pump ** beginning 24 hours after the loading dose NOTE THAT THE DOSE OF ...
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Prescription and OTC Drug Product List 9/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 9: September 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE ATENOLOL CAPSULE; ORAL TABLET; ORAL - DLT - BUTALBITAL, ACETAMINOPHEN, CAFFEINE ATENOLOL - DLT - AB GRAHAM DM 325MG;50MG;40MG N88758 001 - ADD -...
EFFICACY SUPPLEMENTS APPROVED IN CY 2000 EFFICACY SUPPLEMENTS APPROVED IN CY 2000 GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION IBUPROFEN WHITEHALL ROBINS 20-812 15-Jun-98 12-Jan-00 SE5 003 N 18.9 Provides for the use of Infants' Advil (ibuprofen oral suspension) Concentrated Oral Drops, 50 mg/1.25 mL for ages 6 months...
FDA Drug Approvals List- February 1998 Drug Approvals for February 1998 Definitions and Notes February 1998 Original New Drug Applications Original Application #: 050750 Approval Date: 24-FEB-98 Trade Name: ZOSYN Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: LEDERLE PIPERACILLIN INC DIV AMERICAN CYANAMID CO Active Ingredient(s): PIPERACILLIN SODIUM; TAZOBACTAM SODIUM OTC/RX Status: RX...
http://www.fda.gov/cder/foi/label/2000/20793s1lbl.pdf NDA 20- 793/ S- 001 Page 14 Dose of CAFCIT ® (caffeine citrate) Volume Dose of CAFCIT ® (caffeine citrate) mg/ kg Route Frequency Loading Dose 1 mL/ kg 20 mg/ kg Intravenous* (over 30 minutes) One Time Maintenan ce Dose 0.25 mL/ kg 5 mg/ kg Intravenous* (over 10 minutes) or Orally Every 24 hours** * using a syringe infusion pump ** beginning 24 hours after the...
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Report to the Nation: Drug Review Caffeine citrate (Cafcit) is a short-term pediatric treatment for apnea (breathing interruptions), and poractant alfa (Curosurf) can be used for relief from the respiratory distress syndromeCaffeine citrate Cytarabine liposome...
author: OLIVERN
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CDER 1999 Report to the Nation Caffeine citrate (Cafcit) is a short- term pediatric treatment for apnea (breathing interruptions), and poractant alfa (Curosurf) can be used for relief from the respiratory distress syndrome
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
CDER 1999 Report to the Nation page 13
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
CDER 1999 Report to the Nation page 11
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
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FDA Drug Approvals List August 1999 Drug Approvals for September 1999 Definitions and Notes Original New Drug Applications Original Application #: 021079 Approval Date: 24-SEP-99 Trade Name:ALAMAST Chemical Type: 1 Therapeutic Potential: P Dosage Form: SOLUTION Applicant: SANTEN INC Active Ingredient(s): PEMIROLAST POTASSIUM OTC/RX Status: RX Indication(s): For the prevention of itching of the eye due to allergic...
