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Teva Pharmaceutical Industries - News and PR
- - Search Tevapharm: - - Press Release Teva Announces Approval of Enalapril / HCTZ Tablets Jerusalem, Israel, September 19, 2001 - Teva Pharmaceutical Industries Ltd.
Food and Drug Administration (FDA) has issued final approval for the company’s ANDA for ENALAPRIL MALEATE / HYDROCHLOROTHIAZIDE TABLETS.
ENALAPRIL MALEATE / HYDROCHLOROTHIAZIDE...
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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.
FDA final approval to manufacture and market Enalapril Maleate 2.5, 5, 10 and 20mg Tablets.
Enalapril Maleate is the...
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IROA - Scientific Study Reference Search
Pellets 2-Acetamidofluorene (2-AAF) 2-Acetylaminofluorene (AAF) 2-OHE1 3,3',5-Triiodo-L-Thyronine (T3) 4-Hydroxyandrostene-3,17-dione (4-OHA) 4-Hydroxyandrostenedione 5a-Androstan-3a + 17ss-diol 5a-Dihydrotestosterone (5a-DHT) 5a-Dihydrotestosterone (5a-DHT) 5a-Reductase Inhibitor (4MA) 5-Bromo-2'-Deoxyurdine (BrDU) 5a-Dihydrotestosterone (5a-DHT) 6-n-Propyl-2-Thiouracil (PTU...
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Enalapril Maleate - LKT-E5201
- - For Pricing Information click here and submit your country
LKT-E5201 Enalapril Maleate [LKT] - Main Category: Angiotensin-Converting Enzyme/Related Products Related Categories: / Enzyme Inhibitors - General: Product-ID LKT-E5201 Product Name Enalapril Maleate Product Numbers / Sizes: LKT-E5201-G001 1 g - - LKT-E5201-G005 5 g - - Original Manufacturer: LKT Laboratories, Inc
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Angiotensin-Converting Enzyme/Related Products
- - - Family view Angiotensin-Converting Enzyme/Related Products Items 1-8 of 8 Page 1 of 1 - Prod
Prod
Name Brand - ALX-270-212 Captopril ALEXIS LKT-C0261 Captopril LKT LKT-E5201 Enalapril Maleate LKT LKT-E5200 Enalaprilat LKT LKT-L3374 Lisinopril LKT ALX-270-213 S-Nitrosocaptopril ALEXIS LKT-Q8134 Quinapril hydrochloride LKT LKT-T1644 Telmisartan LKT Items 1-8 of 8 Page 1 of...
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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...
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http://www.fda.gov/cder/orange/appendix_a.txt
400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE EC-NAPROSYN, NAPROXEN ECONAZOLE NITRATE, ECONAZOLE NITRATE ECONOCHLOR, CHLORAMPHENICOL ECONOPRED PLUS, PREDNISOLONE ACETATE ECONOPRED, PREDNISOLONE ACETATE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID EDETATE DISODIUM, EDETATE DISODIUM EDEX, ALPROSTADIL EDROPHONIUM CHLORIDE PRESERVATIVE FREE, EDROPHONIUM...
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
LOUIS, MO." 12770 03-Dec-97 BRANTFORD CHEMICALS INC "PAROXETINE HYDROCHLORIDE (ANHYDROUS), MANUFACTURED IN ONTARIO, CANADA." 12774 05-Dec-97 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA "FLUOXETINE HCL USP, MANUFACTURED IN LATINA, ITALY." 12778 10-Dec-97 ORGANICS LAGRANGE INC "ACTIVE PHARMACEUTICAL INGREDIENT-ESTERIFIIED ESTROGENS USP, MANUFACTURED IN CHICAGO,ILLINOIS." 12780 10...
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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
Application No.:- 18-998/S059 Approval Date:-2/13/2001 - Approval Letter(s) - Printed Labeling - Pediatric Data Review - - Medical Review(s) - Chemistry Review(s) - Statistical Review(s) - Microbiology...
author: Paul Stauffer
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../2001/18-998S058_Vasotec
Food and Drug Administration • Center for Drug Evaluation and Research Title Search Vasotec I.V
(Enalapril), (Enalapril Maleate) Tablets, & (Enalapril Maleate/Hydrochlorothiazide) Tablets Company:--Merck and Company, Inc
Application No.:--19-309/S23, 18-998/S58 & 19-221/S26 Approval Date:-11/27/2001 Approval Letter(s) - Printed Labeling -...
author: USERNAME
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http://www.paddocklabs.com/images/PadSec7-1.pdf page 5
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OGD, Tentative Approvals May 2000
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office of Generic Drugs ANDAs Tentative Approvals May 2000 - 1
75-396 MIDAZOLAM HYDROCHLORIDE FAULDING PHARMACEUTICAL 5/5/00 INJECTION 1 MG (BASE)/ML 5 CO
MG (BASE)/ML 2
75-672 BISOPROLOL FUMARATE AND PUREPAC PHARMACEUTICAL 5/11/00 HYDROCHLOROTHIAZIDE CO
TABLETS 2.5 MG/6.25...
author: USERNAME
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OGD, Tentative Approvals June 2000
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office of Generic Drugs ANDAs Tentative Approvals June 2000 1
74-803 FLUOXETINE CAPSULES, USP 10 BARR LABORATORIES, INC
6/14/00 MG 20 MG 2
75-658 FLUOXETINE CAPSULES, USP 10 MALLINCKRODT, INC
6/16/00 MG 20 MG 3
74-504 TAMOXIFEN CITRATE NOVOPHARM LIMITED 6/28/00 TABLETS,...
author: USERNAME
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ANDAs Approvals - August 2000
75-048 ENALAPRIL MALEATE GENEVA PHARMACEUTICALS, 8/22/00 TABLETS, USP 2.5 MG 5 MG 10 INC
75-369 ENALAPRIL MALEATE KRKA, d.d., NOVO MESTO 8/22/00 TABLETS, USP 10 MG 20 MG 5
75-370 ENALAPRIL MALEATE KRKA, d.d., NOVO MESTO 8/22/00 TABLETS, USP 2.5 MG 5 MG 6
75-459 ENALAPRIL MALEATE LEK PHARMACEUTICAL AND 8/22/00 TABLETS USP 10 MG...
author: USERNAME
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ANDA Tentative Approvals - April 2001
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - April 2001 - ANDA Number Drug Name Applicant Tentative Approval Date 1 75-588 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS, USP 200 MG/30 MG PHARMACEUTICAL FORMULATIONS, INC
4/17/01 2 75-788 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS,...
author: USERNAME
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ANDA Tentative Approvals -June 2001
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - June 2001 - ANDA Number Drug Name Applicant Tentative Approval Date 1 75-727 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG, AND 10 MG/25 MG TEVA PHARMACEUTICALS USA 6/8/01 2 75-743 LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20...
author: USERNAME
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ANDA Approvals September 2001
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - September 2001 - - ANDA Number-- Drug Name Applicant Approval Date 1 65-026 TOBRAMYCIN OPHTHALMIC SOLUTION 0.3% ALTANA INC
9/14/01 5 65-047 CEFAZOLIN FOR INJECTION, USP 500 MG/VIAL, 1 G/VIAL, AND 1 G/100 ML INFUSION VIAL
9/18/01 6 75-298 FLUTAMIDE CAPSULES USP 125 MG...
author: USERNAME
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ANDA Approvals October 2001
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - October 2001 - - ANDA Number Drug Name Applicant Approval Date 1 75-839 MINOXIDIL TOPICAL SOLUTION, USP (FOR MEN) 5% (OTC) NOVEX PHARMA 10/1/01 2 75-843 OXAPROZIN TABLETS 600 MG PUREPAC PHARMACEUTICAL CO
10/3/01 3 64-163 GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP 0.3% ...
author: USERNAME
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ANDA Approvals March 2003
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - March 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-455 NOREPINEPHRINE BITARTRATE INJECTION, USP 1 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/4 ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC
3/13/2003- 5 76-174 ETODOLAC EXTENDED-RELEASE TABLETS 400...
author: OGD
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Prescription and Over-the-Counter Drug Product List: 3/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
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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...
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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...
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FDA Drug Approvals List October 2001
- Drug Approvals for October 2001 Definitions and Notes Original New Drug Applications Original Application #: 021356 Approval Date: 26-OCT-01 Trade Name: VIREAD Chemical Type: 1 Therapeutic Potential: P Dosage Form: TABLET Applicant: GILEAD SCIENCES INC Active Ingredient(s): TENOFOVIR DISOPROXIL FUMARATE OTC/RX Status: RX Indication(s): For use in combination with other...
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FDA Drug Approvals List September 2001
- Drug Approvals for September 2001 Definitions and Notes Original New Drug Applications Original Application #: 021279 Approval Date: 25-SEP-01 Trade Name: FORADIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: POWDER, FOR INHALATION Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): FORMOTEROL FUMARATE OTC/RX Status: RX Indication(s): For the long-term, twice...
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FDA Drug Approvals List June 2001
PERRIGO COMPANY Active Ingredient(s): MONOXIDIL OTC/RX Status: RX Original Abbreviated Application # 075750 Approval Date: 8-JUN-01 Trade Name: DOXAZOSIN MESYLATE Dosage Form: TABLET Applicant: SIDMAK LABORATORIES, INC Active Ingredient(s): DOXAZOSIN MESYLATE OTC/RX Status: RX Original Abbreviated Application # 075502 Approval Date: 05-JUN-01 Trade Name: CLOTRIMAZOLE AND...
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