http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...
FDA Guidance Thyroid nodules-- Hyperthyroidism-- Thyroid cancer-- Hypothyroidism-- Graves' Disease-- Thyroiditis-- Radioactive iodine-- Myxedema-- Multinodular goiter-- Hot nodule-- Thyroglossal duct cyst-- Cold nodule-- Thyroglobulin FDA Guidance------------------------------------------------------------------------------ MyThyroid.com - ------ Home Disease Associations Dr
Report to the Nation: Drug Review Food and Drug Administration • Center for Drug Evaluation and Research About CDER - Report Search CDER Report to the Nation: 2000 Table of Contents Drug Review New Drug Review New or Expanded Use Review Over-the-Counter Drug Review Many Americans benefited from last year's timely reviews of new prescription medicines, over-the-counter medicines and their generic equivalents
author: OLIVERN
CDER Template - Replace Title Here Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - June 2002 - Generic Drug Name Generic Manufacturer Brand Name Approval Date- 1- AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, U 200 MG/28.5 MG (BASE)/5 ML, AND 400 MG/57 MG (BASE)/5 ML GENEVA PHARMACEUTICALS, INC
author: USERNAME
Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date Food and Drug Administration • Center for Drug Evaluation and Research Guidance Document Search Guidance for Industry Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications [ PDF version of this document ] U.SLevothyroxine Sodium, Questions and Answers (February...
author: USERNAME
News Along the Pike, July 2000 21, FDA approved the first single-ingredient levothyroxine (T-4) sodium product (Unithroid) Levothyroxine had been marketed in the United States since the 1950s without an NDA, apparently in the belief that it was not a new drug based on its similarity to pre-1938 thyroid extract productsUnithroid as...
author: Oliver
Prescription and OTC Drug Product List 6/2002 -D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
Prescription and OTC Drug Product List 5/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 5: January-May 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE - ADD - ALMOTRIPTAN MALATE CAPSULE; ORAL - ADD - TABLET; ORAL ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE - ADD - AXERT - DLT - + MIKART 150MG;180MG...
http://www.fda.gov/cder/guidance/4647fnl.pdf Guidance for Industry Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications ULevothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date...
http://www.fda.gov/cder/foi/nda/2000/21210_Unithroid_clinphrmr.pdf page 4
http://www.fda.gov/cder/foi/nda/2000/21210_Unithroid_clinphrmr.pdf page 1
http://www.fda.gov/cder/foi/nda/2000/21210_Unithroid_chemr.pdf DIVISION OF METABOLISM AND ENDOCRINE DRUG PRODUCTS HFD- 510 Review of Chemistry, Manufacturing, and Controls NDA #: 21- 210 DATE REVIEWED: 7/ 27/ 00 REVIEW #: 1 REVIEWER: Elsbeth GLevothyroxine Sodium, USP Code Name/#: Chem
http://www.fda.gov/cder/foi/nda/2000/21210_Unithroid_chemr.pdf page 3
duplicates:http://www.fda.gov/cder/drug/infopage/unithroid/cmc1re.pdf
http://www.fda.gov/cder/foi/nda/2000/21210_Unithroid_medr.pdf 1 NDA: 21,210 Dates submitted: 10/ 19/ 99 & 6/ 21/ 2000 Drug: Unithroid (Levothyroxine sodium tablets) Dates rec'd: 10/ 2199 & 6/ 22/ 2000 Sponsor: Jerome Stevens PharmLevothyroxine sodium is a drug with a narrow therapeutic index, therefore, small differences in blood or target tissue concentrations may have adverse clinical consequences, affecting both the...
http://www.fda.gov/cder/foi/nda/2000/21210_Unithroid_medr.pdf page 4
duplicates:http://www.fda.gov/cder/drug/infopage/unithroid/morred.pdf
http://www.fda.gov/cder/foi/nda/2000/21210_Unithroid_medr.pdf page 1
duplicates:http://www.fda.gov/cder/drug/infopage/unithroid/morred.pdf
http://www.fda.gov/cder/foi/nda/2000/21210_Unithroid_memos.pdf Markofsky (Acting Team Leader) Subject: Storage Statement for Jerome Sevens Pharmaceutical's Levothyroxine Sodium (Tablets) Date: 8- 4- 00 In the labeling provided in NDA 21- 210 for their Levothyroxine Sodium (Tablets), Jerome Sevens Pharmaceutical's proposed the following storage statement: "Store at controlled room temperature 150- 300C (59- 860F)" The Chemistry...
http://www.fda.gov/cder/foi/nda/2000/21210lbl.pdf Unithroid (levothyroxine sodium tablets, USP) Page 1 DESCRIPTION UNITHROID™ (levothyroxine sodium tablets, USP) contain synthetic crystalline L- 3,3', 5,5'- tetraiodothyronine sodium salt [levothyroxine (T 4 ) sodium]
duplicates:http://www.fda.gov/cder/drug/infopage/unithroid/21210lbl.pdf
http://www.fda.gov/cder/foi/nda/2000/21210lbl.pdf page 13
duplicates:http://www.fda.gov/cder/foi/label/2000/21210lbl.pdf http://www.fda.gov/cder/drug/infopage/unithroid/21210lbl.pdf
http://www.fda.gov/cder/foi/nda/2000/21210lbl.pdf page 11
duplicates:http://www.fda.gov/cder/foi/label/2000/21210lbl.pdf http://www.fda.gov/cder/drug/infopage/unithroid/21210lbl.pdf
http://www.fda.gov/cder/foi/nda/2000/21210lbl.pdf page 8
duplicates:http://www.fda.gov/cder/foi/label/2000/21210lbl.pdf http://www.fda.gov/cder/drug/infopage/unithroid/21210lbl.pdf
http://www.fda.gov/cder/foi/nda/2000/21210lbl.pdf page 5
duplicates:http://www.fda.gov/cder/foi/label/2000/21210lbl.pdf http://www.fda.gov/cder/drug/infopage/unithroid/21210lbl.pdf
http://www.fda.gov/cder/foi/nda/2000/21210lbl.pdf page 3
duplicates:http://www.fda.gov/cder/foi/label/2000/21210lbl.pdf http://www.fda.gov/cder/drug/infopage/unithroid/21210lbl.pdf
http://www.fda.gov/cder/foi/nda/2000/21210lbl.pdf page 2
duplicates:http://www.fda.gov/cder/foi/label/2000/21210lbl.pdf http://www.fda.gov/cder/drug/infopage/unithroid/21210lbl.pdf
http://www.fda.gov/cder/foi/nda/2000/21210lbl.pdf page 1
duplicates:http://www.fda.gov/cder/foi/label/2000/21210lbl.pdf http://www.fda.gov/cder/drug/infopage/unithroid/21210lbl.pdf
