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,...
Prescription and Over-the-Counter Drug Product List: 8/2003 4 >D> AA + ORTHO MCNEIL PHARM 300MG;60MG N85055 004 AUG DISC >A> @ 300MG;60MG N85055 004 AUG DISC ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA + MALLINCKRODT 500MG/15ML;10MG/15ML N40508 001 AUG 29, 2003 AUG NEWA >D> MIKART 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG CTEC >A> AA 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG...
author: AUTHOR
OGD, First Time Approvals - May 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - May 2002 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1- IDARUBICIN HYDROCHLORIDE FOR INJECTION, USP 5 MG, 10 MG, AND 20 MG SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC
author: OGD
50675S14_Vantin.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Vantin (Cefpodoxime Proxetil) Oral Suspension Company:- Pharmacia & Upjohn Application No.:- 50-675/S014 Approval Date:-11/20/1998 - Approval Letter(s) - Medical Review(s)- - Part 1 - Part 2 - Statistical Review(s) Microbiology Review(s) - Clinical Pharmacology...
author: Paul Stauffer
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_NOV_1998.HTML Firm Date PHENDIMETRAZINE TARTRATE CAPSULE Phendimetrazine Tartrate Capsule 18-074 S-028 Eon 3-Nov-1998 BUTISOL SODIUM Butabarbital Sodium Tablet 00-793 S-015 Wallace 4-Nov-1998 HYDRODIURIL Hydrochlorothiazide Tablet 11-835 S-060 Merck 5-Nov-1998 ATROVENT MDI Ipratropium Bromide 20-394 S-001 Boehringer-Ingelheim 9-Nov-1998 PEPCID AC Famotidine Tablet 20-325 S-007 Merck 9-Nov-1998...
Prescription and OTC Drug Product List 5/2002 2 -D- + ROBINS AH 325MG;15MG N84444 001 MAY DISC -A- @ 325MG;15MG N84444 001 MAY DISC SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -D- AA ALPHARMA 120MG/5ML;12MG/5ML N85861 001 MAY CRLD -A- AA + 120MG/5ML;12MG/5ML N85861 001 MAY CRLD TYLENOL W/ CODEINE -D- AA + JOHNSON RW 120MG/5ML;12MG/5ML N85057 001 MAY DISC -A- @ 120MG/5ML;12MG/5ML N85057 001 MAY DISC TABLET; ORAL...
ranbaxy - - - - -- You are here :- Home - News Room - June 2002 Ranbaxy receives US FDA approval for the Manufacturing and Marketing of Cefpodoxime Proxetil Suspension New Delhi, June 04, 2002 Ranbaxy Pharmaceuticals ...
ranbaxy - - - - -- - You are here :- Home - News Room - June 2002 Ranbaxy receives US FDA approval for the Manufacturing and Marketing of Cefpodoxime Proxetil Suspension New Delhi, June 04, 2002 Ranbaxy ...
FDA Drug Approvals List Active Ingredient(s): NEDOCROMIL SODIUM OTC/RX Status: RX Efficacy Claim: Extending the approved use to the pediatric population of 6-11 years of age Approvable Original New Drug Applications Original Application #: 019781 Approvable Date: 31-MAR-97 Trade Name: PROMETRIUM Dosage Form: CAPSULE Applicant: SCHERING PLOUGH CORP Active Ingredient(s): PROGESTERONE OTC/RX Status: RX...
FDA Drug Approvals List- November 1998 Drug Approvals for November 1998 Definitions and Notes November 1998 Original New Drug Applications Original Application #: 021008 Approval Date: 25-NOV-98 Trade Name: SANDOSTATIN LAR Chemical Type: 3 Therapeutic Potential: P Dosage Form: INJECTABLE Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP Active Ingredient(s): OCTREOTIDE ACETATE OTC/RX Status: RX...
DDPA June 1995 74-423 CAPTOPRIL MOVA CAPTOPRIL 07-JUN-95 (TABLET) CAGUAS, PR 12.5MG 00725 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-911 CLINORIL MERCK SULINDAC 01-JUN-95 (TABLET) WEST POINT, PA 150MG 19486 200MG (LABELING REVISION -- PRECAUTIONS; ADVERSE REACTIONS) 16-744* NORIDAY 1+50-FE SYNTEX FERROUS FUMARATE 02-JUN-95 (TABLET) PALO...
DDPA May 1996 Drug and Device Product Approvals for May 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 16-191 SORBITRATE ZENECA ISOSORBIDE DINITRATE 01-APR-96 (TABLET, SUBLINGUAL) WILMINGTON, DE 2.5MG (SUPPL-033) 19850 5MG (VASODILATOR) [MET CONDITIONS FOR APPROVAL PER FEDERAL REGISTER NOTICE OF AUGUST 3, 1984 (49 FR 31151)] 16-192 SORBITRATE ZENECA ISOSORBIDE DINITRATE 01-APR-96 ...
DDPA March 1996 74-488 RANITIDINE HCL GRANUTEC RANITIDINE HYDROCHLORIDE 05-MAR-96 (TABLET) WILSON, NC EQ 150MG BASE 27896 EQ 300MG BASE (HISTAMINE H-2 RECEPTOR ANTAGONIST) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 04-570 HEPARIN SODIUM UPJOHN HEPARIN SODIUM 04-MAR-96 (INJECTABLE) KALAMAZOO, MI 1,000 UNITS/ML 49001 5,000 UNITS/ML 10,000 UNITS/ML (LABELING REVISION -- WARNINGS; PRECAUTIONS; ADVERSE...
DDPA February 1996 THERE ARE NO ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVALS FOR FEBRUARY 1996 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-123 OMNIS CAN NYCOMED GADODIAMIDE 05-FEB-96 (INJECTABLE) WAYNE, PA 287MG/ML 19087 (LABELING REVISION -- INDICATIONS AND USAGE; DOSAGE AND ADMINISTRATION) 19-099 DOPAMINE HCL AND MCGAW DOPAMINE HYDROCHLORIDE 07-FEB-96 DEXTROSE 5% IRVINE, CA...
Antibiotics for sinusitis - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Antibiotics for sinusitis - [Medication] - Quest Diagnostics Patient Health Library Antibiotics for sinusitis - [Medication] - Quest Diagnostics Patient Health Library Amoxicillin, amoxicillin with clavulanate, amoxicillin with clavulanate potassium,...
Antibiotics for urinary tract infections in children - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Antibiotics for urinary tract infections in children - [Medication] - Quest Diagnostics Patient Health Library Antibiotics for urinary tract infections in children - [Medication] - Quest Diagnostics Patient Health Library Children’s health, Infant and...
Antibiotics for sinusitis - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Antibiotics for sinusitis - [Medication] - Quest Diagnostics Patient Health Library Antibiotics for sinusitis - [Medication] - Quest Diagnostics Patient Health Library Amoxicillin, amoxicillin with clavulanate, amoxicillin with clavulanate potassium,...
Antibiotics for middle ear infection - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Antibiotics for middle ear infection - [Medication] - Quest Diagnostics Patient Health Library Antibiotics for middle ear infection - [Medication] - Quest Diagnostics Patient Health Library Children’s health, Ear, nose, and throat, Infant and toddler...
H:F74S12.PDF NDA 50- 674/ S- 012 NDA 50- 675/ S- 015 Pharmacia & Upjohn Attention: Rebecca SVantin ® (cefpodoxime proxetil) Tablets and Vantin ® (cefpodoxime proxetil) ...
author: Unknown
H:F74S12.PDF page 1
author: Unknown
H:F75S14.PDF NDA 50- 675/ S- 014 Pharmacia & Upjohn Attention: Rebecca SVantin ® (cefpodoxime proxetil) Oral Suspension
author: Unknown
H:F75S14.PDF page 1
author: Unknown
http://www.biosis.org/ts/media/cdjournals/gazettenews/2002/CPG_News_0243.pdf week 0243 25 October 2002 Wyeth has nine applications claiming bi- and tricyclic (di)azepine carboxamides as oxytocin/vasopressin antagonists, continuing the seires from which WAY-VNA-932 has been selected for preclinical studies (see page 21) ISSN:1464-3499 Drug Patenting in Context US authorities to market its 10 mg and 20 mg omeprazole capsules.
Gazette Highlights News 2002 - Thomson Scientific Thomson.com - - - - - Advanced Search - - - EN : JP : CN : KR -- - - Thomson Scientific : Gazette Weekly Highlights News : Gazette Highlights News 2002 - Gazette Highlights News 2002 Click on a week to view more Week 52: We wish all readers a happy and successful New Year!
Maximum Recommended Therapeutic Dose (MRTD) Database Maximum Recommended Therapeutic Dose (MRTD) Database (1,235 pharmaceuticals) A -- B- - C -- D -- E -- F-G -- H-K -- L -- M -- N -- O -- P -- Q-R -- S -- T -- U-Z MRTD--- (mg/kg--- bw/day) -- Generic Chemical Name Chemical Structure (SMILES Code) 3.00000-- Acemetacin C1=C(OC)C=C3C(=C1)N(C(=O)C2=CC=C(Cl)C=C2)C(C)=C3CC(=O)OCC(O)=O 0.20000-- Acenocoumarol C1=CC=C3C(=C1)OC(=O)C(C(CC(C)=O...
