http://www.fda.gov/cder/orange/appendix_a.txt 12, CHLORPHENIRAMINE MALEATE (OTC) CODOXY, ASPIRIN CODRIX, ACETAMINOPHEN COGENTIN, BENZTROPINE MESYLATE COGNEX, TACRINE HYDROCHLORIDE COL-PROBENECID, COLCHICINE COLAZAL, BALSALAZIDE DISODIUM COLBENEMID, COLCHICINE COLD CAPSULE IV, CHLORPHENIRAMINE MALEATE (OTC) COLD CAPSULE V, CHLORPHENIRAMINE MALEATE (OTC) COLESTID, COLESTIPOL HYDROCHLORIDE COLGATE TOTAL, SODIUM FLUORIDE...
Drug Approvals - D ANDA 40-466 5/28/02 4/9/03 - - Diphenhydramine Hydrochloride Injection USP, (Preservative-Free), 50 mg/ml Abbott Laboratories ANDA 40-140 11/20/98 11/20/98 - - Diphenoxylate Hydrochloride & Atropine Sulfate Tablets,2.5 mg/0.025, Rx Able Laboratories, IncDiphenoxylate Hydrochloride & Atropine ...
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 ATROPINE SULFATE AS PRODUCED IN THE INGELHEIM FACILITIES 5497 30-Jul-84 FARCHEMIA SRL "CIMETIDINE MANUFACTURED IN TREVIGLIO (BERGAMO), ITALY." 5498 11-Jun-84 PHARMACIA AND UPJOHN INC "HYDROCORTISONE ACETATE USP,MICRO & NON-MICRO (INFO FORMERLY DMF-1413)" 5500 15-Aug-84 PLANTEX LTD CHEM AND PHARM WORKS "TAMOXIFEN CITRATE USP AS MFG IN THE NETANYA, ISRAEL FACILITIES" 5504...
ANDAs Approvals - May 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals May 2000 - 1HYDROCHLORIDE GENPHARM INCHYDROCHLORIDE EON LABS MANUFACTURING, 5/1/00 TABLETS 80 MG 120 MG 160 MG INCHYDROCHLORIDE ...
author: USERNAME
ANDAs Approvals - November 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals-November 2000 Page: 1 1HYDROCHLORIDE INJECTION 1 MG (BASE)/ML, -- 5 MG (BASE)/ML 2HYDROCHLORIDE IMPAX LABORATORIES, INC
author: USERNAME
1997 Abbreviated New Drug Applications (Generic Drugs) 074946 11/19/1997 3/30/1998 Adriamycin PFS (Doxorubicin Hydrochloride) Injection ,- Adria Laboratories 63165/S3, S5, S6 7/9/1993 8/8/2002 Albuterol Inhalation Aerolsol, 90 mcg/ActuationHydrochloride [2 MB] Taro Pharmaceuticals 074694 12/13/1996 12/3/1997 Clomipramine Hydrochloride Capsules, 25, 50, & 75 mg
Prescription and OTC Drug Product List 8/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST PRESCRIPTION DRUG PRODUCT LIST - 21ST EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 8 - AUG 2001 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL PHRENILIN WITH CAFFEINE AND CODEINE -A- AB AMARIN PHARMS 325MG;50MG;40MG;30MG N74911 001 AUG 22, 2001 AUG NEWA ACETAMINOPHEN;...
Prescription and OTC Drug Product List 7/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS 325MG;7.5MG...
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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 32
author: FDA
subject: 7/21/2000
Prescription and OTC Drug Product List 9/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 9: September 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE ATENOLOL CAPSULE; ORAL TABLET; ORAL - DLT - BUTALBITAL, ACETAMINOPHEN, CAFFEINE ATENOLOL - DLT - AB GRAHAM DM 325MG;50MG;40MG N88758 001 - ADD - MYLAN 25MG...
Prescription and OTC Drug Product List 3/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 3: March 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CAPSULE; ORAL CHLORIDE; SODIUM...
Prescription and OTC Drug Product List 11/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 11: November 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE AMOXICILLIN - ADD - TABLET; ORAL TABLET; ORAL - ADD - TRIZIVIR AMOXICILLIN - ADD - + GLAXO WELLCOME EQ 300MG BASE;150MG;300MG N21205 001 -...
Prescription and OTC Drug Product List 5/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 5: January-May 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE - ADD - ALMOTRIPTAN MALATE CAPSULE; ORAL - ADD - TABLET; ORAL ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE - ADD - AXERT - DLT - + MIKART 150MG;180MG...
Prescription and OTC Drug Product List 2/2001 PEDIATRIC - ADD - @ 10MG;100MG N74080 001 - ADD - + ASTRAZENECA /1VIL;0.02MG/VIAL;0.001MG/VIAL; - ADD - MAR 25, 1994 - ADD - 5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL; - ADD - @ 25MG;100MG N74080 002 - ADD - 17MG/VIAL;0.2MG/VIAL; - ADD - MAR 25, 1994 - ADD - EQ 1MG BASE/VIAL;1.4MG/VIAL; - ADD - @ 25MG;250MG N74080 003 - ADD - EQ 1.2MG BASE/VIAL;0.7MG/VIAL; - ADD - MAR 25, 1994 - ADD - 7MG...
FDA Drug Approvals List May 2000 - Drug Approvals for May 2000 Definitions and Notes Original New Drug Applications Original Application #: 021134 Approval Date: 01-MAY-00 Trade Name: NITROSTAT Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: PARKE DAVIS PHARMACEUTICALS LTD Active Ingredient(s): NITROGLYCERIN OTC/RX Status: RX Indication(s): For the acute relief of an attack or acute...
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 November 2000 - Drug Approvals for November 2000 Definitions and Notes Original New Drug Applications Original Application #: 050782 Approval Date: 27-NOV-00 Trade Name: TRADENAME Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: TARGET RESEARCH ASSOCIATES Active Ingredient(s): CLINDAMYCIN PHOSPHATE OTC/RX Status: RX Indication(s): FOR ONCE A DAY TREATMENT OF ACNE VULGARIS...
http://www.fda.gov/cder/foi/appletter/2000/40395ltr.pdf page 1
http://www.fda.gov/cder/da/ddpa94.wpd 18 473 VENTOLIN GLAXO ALBUTEROL 02 FEB 94 (AEROSOL, METERED) RES TRIANGLE PK, NC 0.09MG/INH 27709 (LABELING REVISION PRECAUTIONS; PATIENT'S INSTRUCTIONS FOR USE) 19 548 TORNALATE STERLING WINTHROP BITOLTEROL MESYLATE 02 FEB 94 (SOLUTION) MALVERN, PA 0.2% 19355 (LABELING REVISION WARNINGS; OVERDOSAGE; DOSAGE AND ADMINISTRATION; PRECAUTIONS) 16 659 NORINYL 1+50 28 DAY SYNTEX (FP)...
Microsoft Word - RPSepicPOM A Aciclovir 6 Acrivastine 6 Aluminium chloride 6 Aspirin 8, 46 Astemizole 5 Atropine Sulphate 9 Azelastine 8, B Beclomethasone Dipropionate 6, 47 Benzocaine 47 Benzoyl Peroxide 46 Budesonide 8 C Cadexomer- Iodine 8 Camphor 47 Carbenoxolone 6 Cetirizine 6,47 Cimetidine 6 Chloramphenicol 9 Clobetasone 9 Clotrimazole 6,8,46 Co- methiamol 29 D Dequalinium chloride 46 Dextranomer 5...
