Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Releases 2004 - 2005: Teva Announces Approval Of Methylprednisolone Acetate Injectable Suspension Jerusalem, Israel, February 24, 2005 Teva and Lundbeck Announce European Approval for AZILECT® (rasagiline) 1mg for Parkinson's Disease Jerusalem, Israel and Copenhagen, Denmark, February 22, 2005 Teva Announces Settlement Of Lamictal® Litigation...
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Announces Approval Of Terbutaline Sulfate Injection Jerusalem, Israel, July 21, 2004 - Teva Pharmaceutical Industries Ltd.Terbutaline Sulfate Injection, 1 mg/mL.
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 ACETAMINOPHEN,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt IN BANGALORE, INDIA" 8062 06-May-89 CIPLA LTD "TERBUTALINE SULFATE AS MFGTERBUTALINE SULFATE MANUFACTURED IN PAULLO (MILANO) ITALY
First-Time Generics -June 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - June 2001 Approval Date Drug Name ANDA Number Supplement Number 6/7/01 METHIMAZOLE TABLETS, USP 20 MG 40-350 S-001 6/15/01 LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG 75-451 6/26/01 TERBUTALINE SULFATE TABLETS, USP 2.5 MG, AND 5 MG 75-877 6/28/01...
author: USERNAME
ANDA Approvals June 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Approvals - June 2001 - ANDA Number Drug Name Applicant Approval Date 1 40-374 TRIAMCINOLONE ACETONIDE OINTMENT, USP 0.025% THAMES PHARMACAL CO., INC
author: USERNAME
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_DEC_1998.HTML 9-Dec-1998 TRIDIL INJECTION Nitroglycerine Injection 18-537 S-015 Faulding 9-Dec-1998 EFFEXOR Venlafaxine Hydrochloride 20-151 S-009 Wyeth Ayerst 9-Dec-1998 NITROGLYCERIN IN DEXTROSE Nitroglycerin 19-970 S-009 Baxter Hlthcare 9-Dec-1998 REBETOL Interferon Alfa-2b, Recombinant Capsules 20-903 S-002 Schering Plough Res 9-Dec-1998 BRETHINE INJECTION Terbutaline Sulfate ...
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_FEB_1999.HTML Firm Date BRETHINE Terbutaline Sulfate Tablet 17-849 032 Novartis Pharms 2-Feb-1999 CHLOROMYCETIN Chloramphenicol Opth Ointment 50-156 038 Parkedale 3-Feb-1999 PRILOSEC Omeprazole Delayed-Release Capsule 19-810 057 Astra Merck 3-Feb-1999 TRANSDERM-NITRO Nitroglycerin Transdermal System 20-144 018 Novartis Pharms 3-Feb-1999 PRIMAXIN Cilastatin Sodium/Imipenem Injection 50...
FDA Drug Approvals List June 2001 Application #: 020702 Efficacy Supplement#: 025 Type: SE8 to Original New Drug Application Approval Date: 08-JUN-01 Trade Name: LIPITOR Dosage Form: TABLET Applicant: PFIZER IRELAND PHARMACEUTICALS Active Ingredient(s): ATORVASTATIN CALCIUM OTC/RX Status: RX Efficacy Claim: As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients...
FDA Drug Approvals List March 2001 Original Application #: 021082 Approval Date: 01-MAR-01 Trade Name: TAVIST ALLERGY/SINUS/HEADACHE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: NOVARTIS CONSUMER HEALTH INC Active Ingredient(s): ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE OTC/RX Status: OTC Indication(s): For temporary relief of symptoms associated with hay fever,...
Prescription and OTC Drug Product List 6/2002 -A- + GD SEARLE LLC EQ 500MG BASE/VIAL N18353 001 JUL CAHN -D- + SCS EQ 500MG BASE/VIAL N18353 001 JUL CAHN MIDAZOLAM HYDROCHLORIDE INJECTABLE; INJECTION MIDAZOLAM HCL -A- AP ABBOTT EQ 1MG BASE/ML N75857 001 JUL 22, 2002 JUL NEWA -A- AP EQ 5MG BASE/ML N75857 002 JUL 22, 2002 JUL NEWA MIDODRINE HYDROCHLORIDE TABLET; ORAL PROAMATINE -A- + SHIRE LABS 5MG N19815 002 SEP 06, 1996 JUL CRLD...
Prescription and OTC Drug Product List 2/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION; ORAL AUGMENTIN '400' -D- + GLAXOSMITHKLINE 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD -A- 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ...
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 8
author: FDA / CBER
subject: December 1987 Guideline
http://www.paddocklabs.com/forms/secundum/volume_6_3.pdf page 6
http://www.paddocklabs.com/forms/secundum/volume_6_3.pdf page 5
http://www.MTRA.com/home/bioanalytical_listing.pdf Bioanalytical Assay List AAI International, Inc. 2320 Scientific Park Drive, Wilmington, NC 28405 USA Phone: 1.800.575.4AAI (4224) Fax: 1.910.815.2300 Bioanalytical Laboratories 12400 Shawnee Mission Parkway, Shawnee Kansas 66216 (P: 913.248.3000 / F: 913.248.3106) Wegenerstrasse 13, ...
http://www.MTRA.com/home/bioanalytical_listing.pdf page 7 AAI International, Inc. 2320 Scientific Park Drive, Wilmington, NC 28405 USA Phone: 1.800.575.4AAI (4224) Fax: 1.910.815.2300 Bioanalytical Laboratories 12400 Shawnee Mission Parkway, Shawnee Kansas 66216 (P: 913.248.3000 / F: 913.248.3106) Wegenerstrasse 13, Neu- Ulm, Germany 89231 (P: ...
duplicates:http://www.aaiintl.com/home/bioanalytical_listing.pdf
Prescription and OTC Drug Product List 6/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 6: June 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMINO ACIDS TABLET; ORAL INJECTABLE; INJECTION PERCOCET NOVAMINE 8.5% - ADD - AA ENDO PHARMS 325MG;5MG N40330 002 - DLT - @ PHARMACIA AND UPJOHN 8.5% N17957 002...
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...
FDA Drug Approvals List March 2000 Original Application #: 021124 Approval Date: 17-MAR-00 Trade Name: LAMISIL Chemical Type: 6 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP Active Ingredient(s): TERBINAFINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of interdigital-type pedis (athlete’s foot), tinea cruris (jock itch)...
Drug and Device Approvals March 1995 74-322 CAPTOPRIL NOVOPHARM CAPTOPRIL 20-MAR-95 (TABLET) WILSON, NC 12.5MG 27396 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) 74-434 CAPTOPRIL MYLAN CAPTOPRIL 22-MAR-95 (TABLET) MORGANTOWN, WV 12.5MG 26505 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) 74-451 CAPTOPRIL ROYCE LABS CAPTOPRIL 31-MAR-95 (TABLET) MIAMI, FL 12.5MG 33014 25MG 50MG 100MG (ANGIOTENSIN...
Drug Approvals for October 1997 Drug Approvals for October 1997 Definitions and Notes October 1997 Original New Drug Applications Original Application #: 020755 Approval Date: 31-OCT-97 Trade Name: CAVERJECT Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PHARMACIA AND UPJOHN CO Active Ingredient(s): ALPROSTADIL OTC/RX Status: RX Indication(s): Provides for an aqueous formulation for...
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