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...
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...
1996 and Older - 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
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 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 "LOTEPREDNOL ETABONATE MANUFACTURED IN ARVILLE CEDEX, FRANCE." 11106 30-Sep-94 3M PHARMACEUTICALS INC "CHLOROFLUOROCARBON PROPELLANT P-11 (TRICHLOROFLUOROMETHANE, NF) MANUFACTURED IN BY ELF ATOCHEM IN VIZCAYA, SPAIN" 11107 30-Sep-94 3M PHARMACEUTICALS INC "CHLOROFLUOROCARBON PROPELLANT P-12 (DICHLOROFLUOROMETHANE,NF) MANUFACTURED BY ELF ATOCHEM IN VIZCAYA,SPAIN." 11108 30-Sep-94 3M...
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...
../96/19-787S007_Norvasc_Amlodipine_Besylate_Tablets Food and Drug Administration • Center for Drug Evaluation and Research Title Search Norvasc (Amlodipine Besylate Company:--Pfizer Central Research Application No.:--19-787/S007 Approval Date:-6/14/1996 Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Chemistry Review(s) - Administrative Document(s) - Correspondence - - Back to Drug...
author: USERNAME
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
FDA Drug Approvals List May 2002 - Drug Approvals for May 2002 Definitions and Notes Original New Drug Applications Original Abbreviated Antibiotic Application # 065082 Approval Date: 31-MAY-02 Trade Name: CEFPODOXIME PROXETIL Dosage Form: GRANULE, FOR RECONSTITUTION Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): CEFPODOXIME PROXETIL OTC/RX Status: RX Original Application #: 021292 Approval Date: 31-MAY...
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...
22173 D TEXT page 12
author: G4-1
withdrawn.PDF page 2
author: walshju
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
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration page 31
author: FDA
subject: 7/21/2000
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...
Drug Approvals January 1997 Drug Approvals for January 1997 Definitions and Notes January 1997 Original New Drug Applications Original Application #: 050733 Approval Date: 30-JAN-97 Trade Name: ZITHROMAX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PFIZER INC Active Ingredient(s): AZITHROMYCIN OTC/RX Status: RX Indication(s): Treatment of patients with community-acquired...
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)...
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 July 2000 - Drug Approvals for July 2000 Definitions and Notes Original New Drug Applications Original Application #: 050779 Approval Date: 27-JUL-00 Trade Name: CEFAZOLIN AND DEXTROSE Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: B BRAUN MEDICAL INC Active Ingredient(s): CEFAZOLIN SODIUM OTC/RX Status: RX Indication(s): For the treatment of respiratory tract...
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...
