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 ...
Prescription and Over-the-Counter Drug Product List: 2/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL -A- CODRIX -A- + ANDRX PHARMS 500MG;15MG N40447 001 FEB 26, 2003 FEB NEWA AZATHIOPRINE TABLET; ORAL AZASAN -A- AAIPHARMA LLC 25MG N75252 002 FEB 03, 2003 FEB NEWA -A- AB 50MG N75252 001 JUN 07, 1999 FEB NEWA -A- 75MG N75252 003 FEB 03, 2003 FEB NEWA -A- 100MG...
author: AUTHOR
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 ...
author: AUTHOR
7200 APAP&Codeine0703 page 2
author: Karen M DiGesu
7200 APAP&Codeine0703 page 1
author: Karen M DiGesu
Esoterix, Inc. -- Test Menu psittaci IgG & IgM antibodies) 607720 Chlamydia pneumoniae/psittaci DNA by PCR *** 606481 Chlamydia DNA Probe 607250 Chlamydia LGV Strain Antibodies, IgG & IgM (Lymphogranuloma Venereum) 607210 Chlamydia pneumoniae Antibodies, IgG & IgM 607290 Chlamydia pneumoniae Antibody, IgG 607291 Chlamydia pneumoniae Antibody, IgM 603335 Chlamydia pneumoniae Antigen 607107 Chlamydia pneumoniae...
author: Esoterix, Inc.
Drug Approvals - A NDA 21-539 1/23/04 2/2/04 2/2/04 Acetaminophen Extended-release Tablets, 650 mg, OTC Coerpharma LLC ANDA 76-200 3/19/02 5/23/02 - - Acetaminophen Extended-release Tablets, 650 mg, OTC LAcetaminophen, Aspirin & Caffeine Tablets, 250 mg/250 mg/65 mg, OTC L
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...
Drug Approvals - B Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg, Rx Able Laboratories, IncAcetaminophen, and Caffeine with Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg, Rx Vintage Pharmaceuticals, IncAcetaminophen, and Caffeine...
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...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt XX 4802 24-Jan-83 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA VERAPAMIL HCL 4813 06-Jan-83 PHARMACIA AND UPJOHN INC METHYLPREDNISOLONE ACETATE 4817 22-Feb-83 OMNICHEM NV (PRB) VERAPAMIL HCL 4827 03-Mar-83 REGIS CHEM CO "4-AMINOPYRIDINE REGIS CODE #002054-PROCESSED-MORTON GROVE, ILL FACILS" 4834 24-Feb-83 ERREGIERRE SPA CHENO DESOXYCHOLIC ACID 4839 11-Mar-83 MALLINCKRODT CHEMICAL...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls KG DOPAMINE HYDROCHLORIDE KYOWA HAKKO KOGYO CO LTD AMINO ACIDS MANUFACTURED AT UBE CITY PLANT JAPAN FABBRICA ITALIANI SINTETICI SPA INDOMETHACIN, USP FRANCIS INDUSTRIA CLIMICA PRODOTTI TOLBUTAMIDE RHONE POULENC PHARMACEUTICALS RP INC BULK ACETAMINOPHEN AS MANUFACTURED AT THE BARTON PLANT IN LULING, LA SYNTEX USA INC FLUNISOLIDE AS MANUF AT THE GRAND BAHAMA AND GUERNAVACA...
Prescription and Over-the-Counter Drug Product List: 8/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> AB VINTAGE PHARMS 325MG;50MG;40MG N40511 001 AUG 27, 2003 AUG NEWA >A> AB 500MG;50MG;40MG N40513 001 AUG 25, 2003 AUG NEWA ESGIC-PLUS >D> AB + MIKART 500MG;50MG;40MG N89451 001 MAY 23, 1988 AUG CTNA >A> AB + 500MG;50MG;40MG...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 6/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE >D> CAPSULE; ORAL >D> PHENAPHEN W/ CODEINE NO
author: AUTHOR
ANDA Approvals - August 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - August 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 65-080 AMOXICILLIN TABLETS FOR ORAL SUSPENSION 200 MG AND 400 MG - RANBAXY LABORATORIES LIMITED 8/11/2003- 2 76-134 LORATADINE TABLETS (OTC) 10 MG - RANBAXY LABORATORIES LIMITED 8/18/2003- 3 76-453 LIDOCAINE...
DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY Food and Drug Administration • Center for Drug Evaluation and Research Approved Drug Products Search DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION - ACETAMINOPHEN; ASPIRIN; BUTALBITAL CAPSULE OR TABLET; ORAL 160-165MG; 160-165MG; 50MG ACETAMINOPHEN; ASPIRIN; BUTALBITAL CAPSULE OR TABLET; ORAL 325MG;...
author: USERNAME
First-Time Generics - August 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - August 2001 - Approval Date Drug Name ANDA Number 8/2/01 FLUOXETINE ORAL SOLUTION, USP 20 MG/5 ML 75-506 8/2/01 FLUOXETINE CAPSULES, USP 20 MG 74-803 8/2/01 FLUOXETINE CAPSULES, USP 40 MG 75-465 8/2/01 FLUOXETINE HYDROCHLORIDE TABLETS 10 MG, AND 20 MG 75-755 8/2...
author: USERNAME
ANDA Approvals November 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - November 2001 - - ANDA Number Drug Name Applicant Approval Date 1 75-916 RIMANTADINE HYDROCHLORIDE TABLETS 100 MG COREPHARMA LLC 11/2/01 2 75-682 IBUPROFEN TABLETS, USP 400 MG, 600 MG, AND 800 MG BASF CORPORATION 11/14/01 3 75-347 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG,...
author: USERNAME
ANDA Approvals - August 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - August 2002 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-452 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 MG/30 MG ABLE LABORATORIES, INCACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 MG...
author: OGD
ANDA Approvals January 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - January 2003 - ANDA Number- Generic Drug Name Applicant Approval Date 1 40-474 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/650 MG ABLE LABORATORIES, INC
author: OGD
ANDA Approvals February 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - February 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 76-028 VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML; PACKAGED IN 10 MG/ML AND 50 MG/5 ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC
author: OGD
Prescription and Over-the-Counter Drug Product List: 1/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE -A- SOLUTION; ORAL -A- ACETAMINOPHEN AND BUTALBITAL AND CAFFEINE -A- + MIKART 325MG/15ML;50MG/15ML;40MG/15ML N40387 001 JAN 31, 2003 JAN NEWA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPAHTE -A- AA ANDRX PHARMS 300MG...
author: AUTHOR
First-Time Generics - March 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - March 2003 - Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 NOREPINEPHRINE BITARTRATE INJECTION, USP 1 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/4 ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC
author: OGD
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
author: OGD
Tylenol w/Codeine TYLENOL ® with Codeine tablets C III (acetaminophen and codeine phosphate tablets) elixir C V (acetaminophen and codeine phosphate oral solution USP) Analgesic For Oral Use Prescribing Information DESCRIPTION Each tablet contains: NoCodeine (acetaminophen and codeine phosphate tablets and...
author: Donna s Madhouse
