Drug Approvals - Z NDA 19-090/S-0037 10/29/99 - 4/16/03 Zantac (ranitidine hydrochloride) Injection & Premixed Injection GlaxoSmithKline NDA 19-090/S-045 & 19-593/S-033 1/7/02 2/8/02 Zantac (ranitidine hydrochloride) Tablets, Syrup, USP, GELdose Capsules & EFFERdose Tablets and Granules GlaxoSmithKline NDA 18-703/S-061, 19-675/S-025, 20-095/S-013 & 20-251/S-011 1/7/02 2/8/02 Zantac (Ranitidine ...
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...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt VANCOMYCIN HYDROCHLORIDE 13224 30-Apr-98 SHANGHAI PIONEER AMPHOTERICIN B 13225 30-Apr-98 ACS DOBFAR SPA CEFADROXIL MONOHYDRATE 13227 21-Sep-98 ZAMBON GROUP SPA "OXAPROZIN, MANUFACTURED IN VICENZE, ITALY" 13228 21-Sep-98 GANES CHEMICALS INC "D-THREO-METHYLPHENIDATE HCL, MANUFACTURED IN PENNSVILLE, NJ" 13230 24-Sep-98 "DSM PHARMA CHEMICALS SOUTH HAVEN, INC." ...
Prescription and Over-the-Counter Drug Product List: 8/2003 4MG/HR N74607 001 AUG 30, 1996 AUG CRLD >A> AB2 + 0.4MG/HR N74607 001 AUG 30, 1996 AUG CRLD >D> AB2 0.6MG/HR N74559 001 AUG 30, 1996 AUG CRLD >A> AB2 + 0.6MG/HR N74559 001 AUG 30, 1996 AUG CRLD >D> TRANSDERM-NITRO >D> AB2 + NOVARTIS 0.1MG/HR N20144 001 FEB 27, 1996 AUG DISC >A> @ 0.1MG/HR N20144 001 FEB 27, 1996 AUG DISC >D> AB2 + 0.2MG/HR N20144 002 FEB 27, 1996 AUG DISC >A> @ 0.2MG...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AP + WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC >A> @ 5,000 UNITS/VIAL N17055 001 JUN DISC >D> AP + 10,000 UNITS/VIAL N17055 002 JUN DISC >A> @ 10,000 UNITS/VIAL N17055 002 JUN DISC GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE >D> AB WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >A> AB + EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >D> WYTENSIN >D> AB WYETH...
author: AUTHOR
FDA Drug Approvals List February 2001 Dosage Form: INJECTABLE Applicant: ASTRAZENECA UK LTD Active Ingredient(s): MEROPENEM OTC/RX Status: RX Application #: 050622 Labeling Supplement #: 014 To Original New Drug Application Approval Date: 06-FEB-01 Trade Name: SUPRAX Dosage Form: SUSPENSION Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO Active Ingredient(s): CEFIXIME OTC/RX Status: RX Application #: 050606...
FDA Drug Approvals List May 2002 - Drug Approvals for May 2002 Definitions and Notes Original New Drug Applications Original Abbreviated Antibiotic Application # 065082 Approval Date: 31-MAY-02 Trade Name: CEFPODOXIME PROXETIL Dosage Form: GRANULE, FOR RECONSTITUTION Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): CEFPODOXIME PROXETIL OTC/RX Status: RX Original Application #: 021292 Approval Date: 31-MAY...
http://www.fda.gov/cder/foi/label/2001/50606s14lbl.pdf 2.4 PV 1982- A AMP VANCOCIN ® HCl Vancomycin Hydrochloride Capsules, USP Pulvules ® This preparation for the treatment of colitis is for oral use only and is not systemically absorbedvancomycin therapy is desired, use Vancocin ® HCl (Sterile Vancomycin Hydrochloride, USP), IntraVenous, and consult package...
http://www.fda.gov/cder/foi/label/2001/50606s14lbl.pdf page 5
http://www.fda.gov/cder/foi/label/2001/50606s14lbl.pdf page 1
V:\DAIDP\PEAT\Approval Letter\N50679SE2.doc NDA 50- 679/ S- 021 Page 3 Rx only 03/ 13/ 03 MAXIPIME ® (Cefepime Hydrochloride) for Injection For Intravenous or Intramuscular Use DESCRIPTION Cefepime hydrochloride is a semi- synthetic, broad spectrum, cephalosporin antibiotic for parenteral administration
author: Raquel Peat
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s GLYBURIDE AND METFORMIN HYDROCHLORIDE BRISTOL MYERS SQUIBB 21-178 SE1 004 30-Nov-01 30-Sep-02 - 10.0 Provides for the use of Glucovance (Glyburide and Metformin HCl) tablets with a thiazolidinedione when glycemic control is not obtained with Glucovance aloneHYDROCHLORIDE ROCHE 20-239 SE1 008 22-Oct-01 16-Aug-02- - 9.8 Provides for the use of KYTRIL ...
author: Darlene Norris
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 25 Iu Somatropin Pituitary & Recombinant 0.20 ru Soybean Oil Emulsion 3.13 mL Spectinomycin HCl 57.00 mg Streptokinase 21428.00 IU Streptokinase- Streptodornase (Local) Streptokinase- Streptodornase 0 Streptomycin Sulfate Streptozocin Succinylcholine Chloride Sufentanil citrate Invert Sugar Invert Sugar in Sodium Chloride Sulbactam Sodium Sulfadiazine Sodium Sulfamethoxazole &...
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 9
author: FDA / CBER
subject: December 1987 Guideline
Corporate Component Name Executive Director US Medical Division Lilly Research Laboratories Eli Lilly and Company 1 PA 1858 AMP VIALS VANCOCIN ® HCl STERILE VANCOMYCIN HYDROCHLORIDE, USP INTRAVENOUS DESCRIPTION Vancocin ® HCl (Sterile Vancomycin Hydrochloride, USP), IntraVenous, is a chromatographically purified, tricyclic glycopeptide antibiotic derived from...
author: Bright Bryn A.
Corporate Component Name page 11
author: Bright Bryn A.
Corporate Component Name page 2
author: Bright Bryn A.
DOCUMENT INFORMATION PAGE The structural formula is as shown: ° HCl Metformin Hydrochloride H3C N H N NH2 CH3 NH NH METAGLIP is available for oral administration in tablets containing 2.5 mg glipizide with 250 mg metformin hydrochloride, 2.5 mg glipizide with 500 mg metformin hydrochloride, and 5 mg glipizide with 500 mg metformin hydrochlorideHydrochloride Monitoring of...
author: James Cross
C:\Data\My Documents\NDA\N21410AP5.doc PRESCRIBING INFORMATION AVANDAMET brand of rosiglitazone maleate and metformin hydrochloride tablets DESCRIPTION AVANDAMET™ (rosiglitazone maleate and metformin HCl) tablets contains two oral antihyperglycemic drugs used in the management of type 2 diabetes: rosiglitazone maleate and metformin hydrochloride
author: Jena Weber
C:\Data\My Documents\NDA\N21178S4AP.doc The structural formula is as shown: ° HCl Metformin Hydrochloride H3C N H N NH2 CH3 NH NH GLUCOVANCE is available for oral administration in tablets containing 1.25 mg glyburide with 250 mg metformin hydrochloride, 2.5 mg glyburide with 500 mg metformin hydrochloride, and 5 mg glyburide with 500 mg metformin hydrochlorideHydrochloride Monitoring...
author: Jena Weber
Diagnostics FORMS - PRO PROPANALOL -------------- PROC CHROMOSOME- PRODUCTS OF C PROD PROTHIADEN(DOTHIEPIN HCL) PROG PROGESTERONE ------------ PROI PROINSULIN -------------- PROL PROLACTIN --------------- PROP PROTHROMBOTIC PROFILE -- PROS PROG / OESTROGEN - SALIVA PROT TOTAL PROTEIN ----------- PROZ FLUOXETINE - (PROZAC) ---- PRS PROTEIN S --------------- PRTE PROTEIN EL'PHORESIS -----...
Prescription and OTC Drug Product List 11/1997 Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 11: Jan '97 - Nov '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE AMANTADINE HYDROCHLORIDE TABLET; ORAL CAPSULE; ORAL PRECOSE - DLT - SYMADINE - DLT - BAYER 25MG N20482 004 - DLT - AB SOLVAY 100MG N71000 001 - DLT - MAY 29, 1997 - DLT - SEP...
Prescription and OTC Drug Product List October 1997 Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 10: Jan '97 - Oct '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE; ORAL OXYCODONE AND ACETAMINOPHEN...
Prescription and OTC Drug Product List 5/2001 IRRIGANT NYSTATIN - ADD - MONARCH PHARMS EQ 40MG BASE/ML; - ADD - @ TEVA 100,000 UNITS/GM N61966 001 - ADD - 200,000 UNITS/ML N60707 001 OINTMENT; TOPICAL - DLT - NILSTAT NETILMICIN SULFATE - DLT - AT + LEDERLE 100,000 UNITS/GM N61444 001 - ADD - @ 100,000 UNITS/GM N61444 001 - DLT - INJECTABLE; INJECTION NYSTATIN - DLT - NETROMYCIN - DLT - AT ALTANA 100,000 UNITS/GM N62124 002 - DLT...
Drug Approvals for May 1997 orbiculare) Application #:020297Efficacy Supplement#:001 Type: SE1 to Original New Drug Application Approval Date: 29-MAY-97 Trade Name: COREG Dosage Form: TABLET Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): CARVEDILOL OTC/RX Status: RX Efficacy Claim: For the new indication of congestive heart failure and a new dosage strength of 3.125 mg Application #...
