Prescription and Over-the-Counter Drug Product List: 1/2004 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETYLCYSTEINE >A> INJECTABLE; INTRAVENOUS >A> ACETADOTE >A> + CUMBERLAND PHARMS 6GM /30ML(200MG/ML) N21539 001 JAN 23, 2004 JAN NEWA ALBUTEROL SULFATE TABLET, EXTENDED RELEASE; ORAL ALBUTEROL SULFATE >D> AB PLIVA EQ 4MG BASE N76130 002 SEP 26, 2002 JAN CRLD >A> + EQ 4MG BASE N76130 002 SEP 26, 2002 JAN CRLD >D> AB EQ 8MG BASE...
Calcium channel blockers for high blood pressure - [Medication] - Quest Diagnostics Patient Health Library Calcium channel blockers for high blood pressure Examples Brand Name Chemical Name Cardizem SR, Dilacor XR, Tiazac diltiazem DynaCirc isradipine Cardene nicardipine Adalat, Procardia XL nifedipine Sular nisoldipine Calan SR, Isoptin SR verapamil Norvasc amlodipine Lotrel amlodipine and benazepril hydrochloride Caduet amlodipine and atorvastatin Plendil felodipine...
Calcium channel blockers for heart attack and unstable angina - [Medication] - Quest Diagnostics Patient Health Library Calcium channel blockers for heart attack and unstable angina Examples Brand Name Chemical Name Norvasc, Caduet [also contains atorvastatin, a cholesterol-lowering medication] amlodipine besylate Cardizem, Dilacor XR, Tiazac diltiazem Plendil felodipine DynaCirc isradipine Cardene nicardipine Procardia XL nifedipine Calan SR, Isoptin SR verapamil Sular nisoldipine...
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 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,...
NDA Approvals for Calendar Year 2004 FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -NDA Approvals for Calendar Year 2004 Updated through January 31, 2004 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE 21604 Children's Elixsure IB Ibuprofen Taro Pharms 5 S 07-Jan-04 21539 Acetadote Acetylcysteine Cumberland Pharms 3 PV 23...
CDER Guidance Documents (Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [ PDF ] M4 Common Technical Document--Quality: Questions and Answers/Location Issues [ HTML ] or [ PDF ] or [ ] (Issued 9/12/2002, Posted 12/30/2002) Quality Q1E Evaluation of...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 14420 AS MANUFACTURED IN DENVER, PENNSYLVANIA" 15121 31-Oct-00 EGIS PHARMACEUTICALS LTD "TAMOXIFEN CITRATE BULK AS MANUFACTURED IN BUDAPEST, KORMEND, HUNGARY" 15122 30-Oct-00 RHODES TECHNOLOGIES "MILLING OF ACTIVE PHARMACEUTICAL INGREDIENTS, EXCIPIENTS & FINE CHEMICALS MANUFACTURED IN COVENTRY, RI" 15125 31-Oct-00 FAKO ILACLARI A S BUYUKDERE "RANITIDINE HYDROCHLORIDE FORM I BULK AS...
http://www.fda.gov/cder/dmf/text/4Q2003NEWTEXT.txt CHINA." 16892 V 3-Sep-2003 ALTHEA TECHNOLOGIES INC "ASEPTIC FORMULATION, FILL, AND FINISH FACILITY IN SAN DIEGO, CA." 16893 III 15-Sep-2003 ERIE MOLDED PLASTICS INC "LID FOR DEODORANT AS MANUFACTURED IN ERIE, PA." 16894 II 5-Oct-2003 DIVIS LABORATORIES LTD "LEVITERACETAM AS MANUFACTURED IN ANDHRA PRADESH, INDIA." 16895 IV 6-Oct-2003 FIRMENICH INC "NATURAL & ARTIFICIAL ORANGE FLAVOR...
http://www.fda.gov/cder/dmf/xls/4Q2003NEWEXCEL.xls LOUIS, MO IV SYMRISE 823992 NATURAL & ARTIFICIAL CAPPUCCINO TYPE FLAVOR CONCENTRATE AS MANUFACTURED IN TETERBORO, TOTOWA AND BRANCHBURG, NJ II GLENMARK PHARMACEUTICALS LTD CILOSTAZOL AS MANUFACTURED IN GUJARAT STATE, INDIA II MILLIPORE CORP MILLIPORE CORPORATION EXPRESS(R) MEMBRANE AND FILTERS AS MANUFACTURED IN BEDFORD, MA AND JEFFREY, NH III EASTMAN CHEMICAL COMPANY EASTAPAK(R) AND...
1997 New Drug Application (NDA) New Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
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 AUG...
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CDER Guidance Documents (Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) M2 Electronic Common Technical Document Specification [ HTML ] or [ PDF ] (Issued 6/2002, Posted 6/13/2002) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [ PDF ] M4 Common Technical Document--Quality: Questions and Answers...
Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 36
author: FDA
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...
EFFICACY SUPPLEMENTS APPROVED IN CY 2000 EFFICACY SUPPLEMENTS APPROVED IN CY 2000 GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION IBUPROFEN WHITEHALL ROBINS 20-812 15-Jun-98 12-Jan-00 SE5 003 N 18.9 Provides for the use of Infants' Advil (ibuprofen oral suspension) Concentrated Oral Drops, 50 mg/1.25 mL for ages 6 months...
http://www.fda.gov/cber/gdlns/guidelst.txt Preliminary Guidance Implementation Plan USP injection October 2, 1995 Do Do nomenclature In Vivo Bioequivalence Studies of April 22, 1996 Do Do Clozapine Instructions for Filing Supplements April 11, 1996 Do Do Under the Provisions of SUPAC-IR Seventh of a series of letters about July 29, 1988 Do Do the Act providing guidance on the ``180-day exclusivity'' provision of section 505(j...
http://www.fda.gov/cber/gdlns/anguidlst.txt Preliminary Guidance -------------------------------------------------------------------------------------------------------------------------------------------------------- Implementation Plan USP injection nomenclature October 2, 1995 Do Do -----------------------------------------------------------------------------------------------------------------------------------------------...
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...
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) SPRING HOUSE,...
DDPA January 1995 74-124 CIPROFLOXACIN BARR CIPROFLOXACIN 04-JAN-95 (TABLET) POMONA, NY 250MG 10970 500MG 750MG (ANTIBACTERIAL, QUINOLONE) 74-363 CAPTOPRIL GENEVA CAPTOPRIL 30-JAN-95 (TABLET) BROOMFIELD, CO 12.5MG 80038 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-521 DEXTROSE 10% BAXTER HLTHCARE DEXTROSE 05-JAN-95 IN PLASTIC CONTAINER ROUND...
DDPA June 1996 74-515 TIMOLOL MALEATE AKRON TIMOLOL MALEATE 17-JUN-96 (SOLUTION) DECATUR, IL EQ 0.25% BASE 62525 (BETA ADRENERGIC BLOCKER) 74-516 TIMOLOL MALEATE AKRON TIMOLOL MALEATE 17-JUN-96 (SOLUTION) DECATUR, IL EQ 0.5% BASE 62525 (BETA ADRENERGIC BLOCKER) 16-096 MINTEZOL MSD THIABENDAZOLE 03-JUN-96 (TABLET, CHEWABLE) WEST POINT, PA 500MG 19486 (LABELING REVISION -- INDICATIONS AND USAGE;...
DDPA April 1996 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-262 TAXOL BRISTOL MYERS SQUIBB PACLITAXEL 01-APR-96 (INJECTABLE) WALLINGFORD, CT 6MG/ML 06492 (LABELING REVISION -- BOXED WARNING; DESCRIPTION; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION; HOW SUPPLIED) 18-602 CARDIZEM HOECHST MARION RSSL DILTIAZEM HYDROCHLORIDE 02-APR-96 (TABLET) KANSAS CITY, MO 30MG 64134 60MG...
Statins for high cholesterol - [Medication] - Quest Diagnostics Patient Health Library Statins for high cholesterol Examples Brand Name Chemical Name Mevacor lovastatin Altocor extended-release lovastatin Pravachol pravastatin Zocor simvastatin Lescol, Lescol XL fluvastatin Lipitor, Caduet [also contains amlodipine, a calcium channel blocker] atorvastatin Crestor rosuvastatin Vytorin ezetimibe and simvastatin Advicor extended-release niacin and...
