Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Received Two Approvals:Final Approval for Enalapril to be Shipped Immediately Tentative Approval for Loratadine Jerusalem, Israel, August 23, 2000 - Teva Pharmaceutical Industries Ltd.Enalapril Maleate 2.5, 5, 10 and 20mg Tablets.Enalapril Maleate is the...
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
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,...
18-998S059_Vasotec.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Vasotec (Enalapril Maleate) Tablets Company:- Merck and Company Inc
author: Paul Stauffer
../2001/18-998S058_Vasotec Food and Drug Administration • Center for Drug Evaluation and Research Title Search Vasotec I.VEnalapril), (Enalapril Maleate) Tablets, & (Enalapril Maleate/Hydrochlorothiazide) Tablets Company:--Merck and Company, Inc
author: USERNAME
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 50-587 50-630...
FDA Drug Approvals List November 2001 REDDY'S LABORATORIES LIMITED Active Ingredient(s): IBUPROFEN OTC/RX Status: RX Original Abbreviated Application # 075347 Approval Date: 16-NOV-01 Trade Name:OMEPRAZOLE Dosage Form: CAPSULE Applicant: ANDRX PHARMACEUTICALS, INC Active Ingredient(s): OMEPRAZOLE OTC/RX Status: RX Original Abbreviated Application # 075682 Approval Date: 14-NOV-01 Trade Name:IBU Dosage Form: TABLET...
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...
TEVA Pharmaceutical Industries Ltd - - - - Teva Earnings per share for Q3 2000 rise 26% Copaxone sales rise 59% Consolidated Statements of Income Balance Sheet Data Sales for the Quarter ended September 30 Jerusalem, Israel, November 7, 2000 - Teva Pharmaceutical Industries Ltd.
http://www.fda.gov/cder/foi/label/2001/18998s58lbl.pdf DESCRIPTION VASOTEC * (Enalapril Maleate) is the maleate salt of enalapril, the ethyl ester of a long- acting angiotensin converting enzyme inhibitor, enalaprilatVASOTEC ® (Enalapril Maleate) 7825159 2 While the mechanism through which VASOTEC lowers...
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http://www.fda.gov/cder/foi/label/2001/19309s23lbl.pdf Because of the potential for serious adverse reactions in nursing infants from enalapril, a decision should be made whether to discontinue nursing or to discontinue VASOTEC IEnalapril Maleate Since enalapril is converted to enalaprilat, those adverse experiences associated with enalapril might also be expected to occur with VASOTEC I
