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http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN...
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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...
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Prescription and OTC Drug Product List 5/2001
IRRIGANT NYSTATIN - ADD - MONARCH PHARMS EQ 40MG BASE/ML; - ADD - @ TEVA 100,000 UNITS/GM N61966 001 - ADD - 200,000 UNITS/ML N60707 001 OINTMENT; TOPICAL - DLT - NILSTAT NETILMICIN SULFATE - DLT - AT + LEDERLE 100,000 UNITS/GM N61444 001 - ADD - @ 100,000 UNITS/GM N61444 001 - DLT - INJECTABLE; INJECTION NYSTATIN - DLT - NETROMYCIN - DLT - AT ALTANA 100,000 UNITS/GM N62124 002 - DLT...
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
NAPROXEN 2033 22-Dec-72 SCHERING AG NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) 2035 28-Dec-72 PHARMACIA AND UPJOHN INC TRIAMCINOLONE 2048 08-Feb-73 PFANSTIEHL LABORATORIES INC CREATINE 2063 15-Jan-73 PALL CORP FILTER CARTRIDGE 2098 27-Apr-73 PHARMACIA AND UPJOHN SPA ADRIAMYCIN HCL BULK 2115 14-Jun-73 LUNDBECK PHARMACEUTICALS ITALY SPA HYDROCHLOROTHIAZIDE USP 2140 07-Aug-73 SOLMAG...
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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
NAPROXEN SCHERING AG NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) PHARMACIA AND UPJOHN INC TRIAMCINOLONE PFANSTIEHL LABORATORIES INC CREATINE PALL CORP FILTER CARTRIDGE PHARMACIA AND UPJOHN SPA ADRIAMYCIN HCL BULK LUNDBECK PHARMACEUTICALS ITALY SPA HYDROCHLOROTHIAZIDE USP SOLMAG S.P.A PHENDIMETRAZINE TARTRATE SIFAVITOR SPA TRICHLORMETHIAZIDE NF XIII LILLY RES LABS DIV...
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http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_NOV_1998.HTML
Firm Date PHENDIMETRAZINE TARTRATE CAPSULE Phendimetrazine Tartrate Capsule 18-074 S-028 Eon 3-Nov-1998 BUTISOL SODIUM Butabarbital Sodium Tablet 00-793 S-015 Wallace 4-Nov-1998 HYDRODIURIL Hydrochlorothiazide Tablet 11-835 S-060 Merck 5-Nov-1998 ATROVENT MDI Ipratropium Bromide 20-394 S-001 Boehringer-Ingelheim 9-Nov-1998 PEPCID AC Famotidine Tablet 20-325 S...
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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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Prescription and OTC Drug Product List 3/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ALBUTEROL SULFATE AEROSOL, METERED; INHALATION PROVENTIL-HFA -D- + 3M EQ 0.09MG BASE/INH N20503 001 AUG 15, 1996 MAR CTEC -A- BX + EQ 0.09MG BASE/INH N20503 001 AUG 15, 1996 MAR CTEC VENTOLIN HFA -D- + GLAXOSMITHKLINE EQ 0.09MG BASE/INH N20983 001 APR 19, 2001 MAR CTEC -A- BX + EQ 0.09MG BASE/INH N20983 001 APR 19, 2001 MAR CTEC...
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Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 37
author: FDA
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Annual Comprehensive List of Guidance Documents at the Food and Drug Administration page 33
author: FDA
subject: 7/21/2000
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Prescription and OTC Drug Product List 11/1997
Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 11: Jan '97 - Nov '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE AMANTADINE HYDROCHLORIDE TABLET; ORAL CAPSULE; ORAL PRECOSE - DLT - SYMADINE - DLT - BAYER 25MG N20482 004 - DLT - AB SOLVAY 100MG N71000 001 - DLT - MAY 29, 1997 - DLT - SEP 04,...
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Prescription and OTC Drug Product List 6/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 6: June 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMINO ACIDS TABLET; ORAL INJECTABLE; INJECTION PERCOCET NOVAMINE 8.5% - ADD - AA ENDO PHARMS 325MG;5MG N40330 002 - DLT - @ PHARMACIA AND UPJOHN 8.5% N17957 002...
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Prescription and OTC Drug Product List 9/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 9: September 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE - ADD - ARSENIC TRIOXIDE TABLET; ORAL - ADD - INJECTABLE; INJECTION HYDROCODONE BITARTRATE AND ACETAMINOPHEN - ADD - TRISENOX - ADD - AA MALLINCKRODT 325MG...
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Prescription and OTC Drug Product List 3/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 3: March 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST LIST 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 3 / JAN'2000 - MAR'2000 ACETAMINOPHEN; BUTALBITAL AMINOPHYLLINE CAPSULE; ORAL TABLET; ORAL PHRENILIN...
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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...
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http://www.fda.gov/cber/gdlns/anguidlst.txt
Preliminary Guidance -------------------------------------------------------------------------------------------------------------------------------------------------------- Implementation Plan USP injection nomenclature October 2, 1995 Do Do -----------------------------------------------------------------------------------------------------------------------------------------------...
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FDA Drug Approvals List- June 1999
ROBINS COMPANY Active Ingredient(s): ISOSORBIDE MONONITRATE OTC/RX Status: RX Application #: 018074 Labeling Supplement#: 029 To Original New Drug Application Approval Date: 16-JUN-99 Trade Name: PHENDIMETRAZINE TARTRATE Dosage Form: CAPSULE, EXTENDED RELEASE Applicant: EON LABORATORIES Active Ingredient(s): PHENDIMETRAZINE TARTRATE OTC/RX Status: RX...
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http://www.fda.gov/cder/ogd/rld/18074s28.pdf
Each capsule, for oral administration, contains 105 mg Phendimetrazine Tartrate manufactured in a special base designed for prolonged release
The active drug, 105 mg of Phendimetrazine Tartrate in each capsule of this special extended- release dosage form approximates the action of three 35 mg immediate release doses taken at four hour intervals
Studies...
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http://www.fda.gov/cder/ogd/rld/18074s28.pdf page 3
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http://www.fda.gov/cder/ogd/rld/18074s28.pdf page 2
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http://www.fda.gov/cder/ogd/rld/18074s28.pdf page 1
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FDA Drug Approvals List- November 1998
Drug Approvals for November 1998 Definitions and Notes November 1998 Original New Drug Applications Original Application #: 021008 Approval Date: 25-NOV-98 Trade Name: SANDOSTATIN LAR Chemical Type: 3 Therapeutic Potential: P Dosage Form: INJECTABLE Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP Active Ingredient(s): OCTREOTIDE ACETATE OTC/RX Status: RX...
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