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 Tentative Approval Of Benazepril Hcl Tablets, 5 Mg, 10 Mg, 20 Mg, And 40 Mg Jerusalem, Israel, November 7, 2003 - Teva Pharmaceutical Industries Ltd.Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg.
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Releases 2003: Teva Announces Tentative Approval of Terbinafine HCL Tablets Jerusalem, Israel, December 19, 2003 Teva Announces Filing of Universal Shelf Registration Statement Jerusalem, Israel, December 12, 2003 Teva and Andrx Announce Collaboration on Generic Oral Contraceptive Products Jerusalem, Israel, December 10, 2003 Teva Announces Approval of...
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Announces Final Approval Of Benazepril Hcl Tablets, 5 Mg, 10 Mg, 20 Mg, And 40 Mg Jerusalem, Israel, February 11, 2004 - Teva Pharmaceutical Industries Ltd.Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg.Benazepril ...
http://www.novartis.com/downloads/Cibacen_Cibadrex_Non_Confidential_Summary.pdf ® = Registered trademark of Novartis AG, Basel, Switzerland Cibacen®/ Lotensin® (Benazepril Hydrochloride) & Cibadrex®/ Lotensin HCT® (Benazepril Hydrochloride and Hydrochlorothiazide) Product Acquisition Opportunity Europe Non- Confidential Summary July 2004 Non- Confidential Summary 2 Table of Contents (from the Confidential Information Memorandum) 1.
duplicates:http://www.novartis.com/downloads/Cibacen_Cibadrex_Non_Confidential_Summary.pdf
What's new at CDER by Date New and Generic Drug Approvals Agenerase (amprenavir) Capsules and Oral Solution, GlaxoSmithKline Benazepril Hydrochloride Tablets, Genpharm, IncBenazepril Hydrochloride Tablets, Mylan Pharmaceuticals Benazepril Hydrochloride Tablets, Ranbaxy Benazepril Hydrochloride Tablets, Andrx Pharmaceuticals ...
author: Paul Stauffer
Drug Approvals - B ANDA 76-476 2/11/04 - - - Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Mylan Pharmaceuticals ANDA 76-430 2/11/04 - - - Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved Mylan Pharmaceuticals ANDA 76-430 1/23/04 - - - Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Eon Labs, Inc
BENAZEPRIL HCI! page 2
author: Jamie Dorgan
BENAZEPRIL HCI! page 1
author: Jamie Dorgan
Tentative Approvals - January 2004 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Tentative Approvals - January 2004 - ANDA Number Generic Drug Name Applicant Tentative Approval Date 1 76-315 TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG - BARR LABORATORIES, INC
http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt LISINOPRIL CRUDE AS MFG IN COURBEVOIE AND HAM FRANCE 14537 19-Nov-99 FUJISAWA PHARMACEUTICAL CO LTD FK8453 DRUG SUBSTANCE AS MFG IN HYOGO AND OSAKA JAPAN 14538 09-Nov-99 SICOR DE MEXICO SA DE CV AMCINONIDE AS MFG IN LERMA MEXICO 14539 18-Nov-99 "UQUIFA ITALIA, S.P.A." CLINDAMYCIN HYDROCHLORIDE USP AS MFG IN MILAN ITALY 14540 18-Nov-99 DIOSYNTH BV TESTOSTERONE UNDECANOATE AS MFG...
Tentative Approvals - November 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Tentative Approvals - November 2003 - ANDA Number Generic Drug Name Applicant Tentative Approval Date 1 76-355 ALBUTEROL SULFATE INHALATION SOLUTION, USP 0.042% (BASE) PACKAGED IN 1.5 MG (BASE)/3 ML UNIT-DOSE VIALS - NEPHRON PHARMACEUTICALS CORPORATION 11/7/2003- 2 76-118 BENAZEPRIL ...
Generic Tentative Approvals -February 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - February 2003 - ANDA Number Generic Drug Name Applicant Tentative Approval Date 1 76-213 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG ROXANE LABORATORIES, INC
author: OGD
Prescription and OTC Drug Product List 8/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -A- AA ABLE 300MG;30MG N40452 001 AUG 01, 2002 AUG NEWA -A- AA 300MG;60MG N40459 001 AUG 01, 2002 AUG NEWA ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE TABLET; ORAL ACETAMINOPHEN AND PENTAZOCINE HCL -A- AB AMIDE PHARM 650MG;EQ 25MG BASE N76202 001...
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s ----------- This list is updated quarterly.- Updated through 12/31/02 -------------------- Top of Page ---------- EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE8)* Top of Page GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE GLAXOSMITHKLINE 21-205 SE8...
author: Darlene Norris
ranbaxy - - - - - You are here :- Home - International Operations - - Global API- Products PRODUCTS Anti-Infectives Semi-synthetic Penicillins Amoxycillin Trihydrate Ampicillin Trihydrate Cloxacillin Sodium ...
ranbaxy - - - - - - You are here : Home - Products - - APIs GLOBAL API Active Pharmaceutical Ingredients(API) Ranbaxy's Global API business is a combination of commodity and technology products operating in regulated ...
Drug Approvals for April 1997 Dosage Form: GRANULE Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV Active Ingredient(s): ERYTHROMYCIN ETHYLSUCCINATE OTC/RX Status: RX Application #: 020564 Labeling Supplement #: 002 To Original New Drug Application Approval Date: 11-APR-97 Trade Name: EPIVIR Dosage Form: TABLET Applicant: GLAXO WELLCOME Active Ingredient(s): LAMIVUDINE OTC/RX Status: RX Application #:...
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- June 1999 Drug Approvals for June 1999 Definitions and Notes June 1999 Original New Drug Applications Original Application #: 020968 Approval Date: 30-JUN-99 Trade Name: MONISTAT DUAL PAK Chemical Type: 3 Therapeutic Potential: S Dosage Form: SUPPOSITORY Applicant: ADVANCED CARE PRODUCTS Active Ingredient(s): MICONAZOLE NITRATE OTC/RX Status: RX Indication(s): TREATMENT OF VULVOVAGINAL...
FDA Drug Approvals List- July 1998 Drug Approvals for July 1998 Definitions and Notes July 1998 Original New Drug Applications Original Application #: 020822 Approval Date: 17-JUL-98 Trade Name: CELEXA Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: FOREST LABORATORIES INC Active Ingredient(s): CITALOPRAM HYDROBROMIDE OTC/RX Status: RX Indication(s): TREATMENT OF DEPRESSION Original...
DDPA November 1995 74-493 CAPTOPRIL PAR CAPTOPRIL 14-NOV-95 (TABLET) SPRING VALLEY, NY 12.5MG 10977 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 19-543 ELOCON SCHERING MOMETASONE FUROATE 03-OCT-95 (OINTMENT) KENILWORTH, NJ 0.1% 07033 (LABELING REVISION -- INDICATIONS AND USAGE; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION) 19-625...
DDPA May 1995 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 19-915 MONOPRIL BRISTOL MYERS SQUIBB FOSINOPRIL SODIUM 02-MAY-95 (TABLET) PRINCETON, NJ 10MG 08543 20MG 40MG (LABELING REVISION -- CLINICAL PHARMACOLOGY; INDICATIONS AND USAGE; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION) 18-206* LO/OVRAL-28 WYETH AYERST LABS ETHINYL ESTRADIOL 03-MAY-95 AND FERROUS FUMARATE PHILADELPHIA, PA 0.03MG (TABLET)...
Drug and Device Approvals March 1995 Drug and Device Approvals-March 1995 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-092 DILACOR XR RHONE POULENC RORER DILTIAZEM HYDROCHLORIDE 02-MAR-95 (CAPSULE, COLLEGEVILLE, PA 120MG (SUPPL-005)EXTENDED RELEASE) 19426 180MG 240MG (NEW INDICATION -- MANAGEMENT OF CHRONIC STABLE ANGINA) 20-281 ULTRAM JOHNSON RW TRAMADOL HYDROCHLORIDE 03-MAR-95 (TABLET)...
