IROA - Scientific Study Reference Search Pellets 2-Acetamidofluorene (2-AAF) 2-Acetylaminofluorene (AAF) 2-OHE1 3,3',5-Triiodo-L-Thyronine (T3) 4-Hydroxyandrostene-3,17-dione (4-OHA) 4-Hydroxyandrostenedione 5a-Androstan-3a + 17ss-diol 5a-Dihydrotestosterone (5a-DHT) 5a-Dihydrotestosterone (5a-DHT) 5a-Reductase Inhibitor (4MA) 5-Bromo-2'-Deoxyurdine (BrDU) 5a-Dihydrotestosterone (5a-DHT) 6-n-Propyl-2-Thiouracil (PTU...
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, ...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt IN ANDHRA PRADESH, INDIA." 10830 24-Mar-94 YUNG ZIP CHEMICAL INDUSTRY CO LTD AIC "ACYCLOVIR MANUFACTURED IN TACHIA, TAIWAN, REPUBLIC OF CHINA." 10836 30-Mar-94 KYOWA HAKKO KOGYO CO LTD "SODIUM HYALURONATE MANUFACTURED IN UBE-SHI, JAPAN." 10837 28-Mar-94 ERREGIERRE SPA "FLUOXETINE HYDROCHLORIDE MANUFACTURED IN BERGAMO, ITALY." 10838 29-Mar-94 SANDOZ GMBH "7-AMINO-3-PROPENYL...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003 TYPE2ACTIVEEXCEL DMF # SUBMIT DATE HOLDER SUBJECT CENTRAL SOYA SOYBEAN STEROL PRODUCTS INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE ...
Ortho-McNeil: Our Products Also available as 15mg and 25mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food AXERT ® Tablets (almotriptan malate) Migraine Oral medication for acute treatment of migraine with or without aura in adults; available in 6.25mg and 12.5mg, 6-tablet blister - PARAFON FORTE ® DSC Caplets (chlorzoxazone) Pain Management Centrally...
Ortho-McNeil: Our Products Prescribing Information - ALL-FLEX ® Arcing Spring Diaphragm Contraceptive Molded, dry natural rubber vaginal diaphragm containing a distortion-free, dual spring-within-a-spring AXERT ® Tablets (almotriptan malate) Migraine Oral medication for acute treatment of migraine with or without aura in adults; available in 6.25mg and 12.5mg, 6-tablet blister - DITROPAN ® ...
Microsoft Word - Medication_Listing.doc moclobemide (Manerix®) 150 mg tab nortriptyline (Aventyl®) 10 mg, 25 mg cap Continuing Care Pharmacy & Therapeutics Formulary ML- 01 SECTION SUBJECT Page 17 of 38 MEDICATION LISTING (ML) Medication Listing YY MM DD Original 00 10 30 Revised 02 01 14 Revised 03 10 23 paroxetine (Paxil®) 10 mg, 20 mg, 30 mg sertraline (Zoloft®) 25mg, 50 mg, 100 mg cap...
author: Wendy Daws
Microsoft Word - Medication_Listing.doc page 17
author: Wendy Daws
Microsoft Word - Master_Index.doc 025% (Synalar®, Synamol®) Autosubstitution to betamethasone valerate 0.1% (ASL- 34 84: 06 fluocinonide 0.01% (Lidex®) Autosubstitution for intermediate potency topical corticosteroids (ASL – 01) 33 84: 06 fluocinonide 0.05% (Lidex®) Autosubstitution for high potency topical corticosteroids (ASL – 01) 33 84: 06 fluorouracil (5- FU®, Efudex®)...
author: Wendy Daws
Haldol Dec PI HALDOL ® Decanoate 50 (haloperidol) HALDOL ® Decanoate 100 (haloperidol) For IM Injection Only Prescribing Information DESCRIPTION Haloperidol decanoate is the decanoate ester of the butyrophenone, HALDOL (haloperidol) Decanoate 50 and HALDOL Decanoate 100 are the long- acting forms of HALDOL (...
author: Donna
Haldol Dec PI page 2
author: Donna
Haldol Dec PI page 1
author: Donna
Prescription and Over-the-Counter Drug Product List: 5/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
75-176_Haloperidol Decanoate Injection Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Haloperidol Decanoate Injection Company:--King Pharmaceuticals, Inc
author: Paul Stauffer
FDA Drug Approvals List April 2002 JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): HALOPERIDOL DECANOATE OTC/RX Status: RX Application #: 015923 Labeling Supplement #: 072 To Original New Drug Application Approval Date: 17-APR-02 Trade Name: HALDOL Dosage Form: INJECTABLE Applicant: R.WHALOPERIDOL OTC/RX Status: RX...
Prescription and OTC Drug Product List 12/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL SYNALGOS-DC-A -A- @ WOMEN FIRST HLTHCARE 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN -D- @ WYETH AYERST 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL ANEXSIA 5/325 -D- AA MALLINCKRODT 325MG;5MG N40409...
Prescription and OTC Drug Product List 8/2001 ACTHAR GEL -D- BC + AVENTIS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -D- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN -A- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -A- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN DELAVIRDINE MESYLATE TABLET; ORAL RESCRIPTOR -D- + AGOURON 100MG N20705 001 APR 04, 1997 AUG CRLD -A- 100MG N20705 001 APR 04, 1997 AUG...
2003 Export Products List Alphabetical ADULTS 5760634204 pms- Fluphenazine 0.5mg/ mL Elixir 500mL 5760612752 pms- Fluphenazine Decanoate Injection 25mg/ ml 5mL Modecate Antipsychotic: Long- acting parenteral preparations for the management of manifestations of chronic schizophreniaHaloperidol - LA 100mg/ mL Injection 5 X 1mL 5760607082 pms- Haloperidol - LA 100mg/ mL Injection...
author: Lee S. Ehler
Export Products List by System July 2003 page 41
author: Lee S. Ehler
FDA Drug Approvals List February 2000 - Drug Approvals for February 2000 Definitions and Notes Original New Drug Applications Original Application #: 021015 Approval Date: 28-FEB-00 Trade Name: ANDROGEL Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: UNIMED PHARMACEUTICALS INC Active Ingredient(s): TESTOSTERONE OTC/RX Status: RX Indication(s): For replacement therapy in males for conditions...
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices Conc.( equine) 3.00 mL Dipyridamole 0.14 mg Dobutamine HCI 0.90 mg 5.00 1.10 2.17 3.57 1.80 1.80 1.80 1.80 45.45 5.00 1.25 5.56 11.60 + 0.50 + 35.70 + 71.43 16.70 + 17.20 + 0.70 + 0.70 + 111.00 + 200.00 + 1.00 357.00 0.003 + 0.50 + 166.67 1.00 4.00 0.50 + 1.00 8.77 3.40 + 16.67 1.67 37.70 5.56 40 Dopamine HCI Dopamine HCl in Dextrose Doxapram HCI Injection Doxorubicin HCI for...
author: FDA / CBER
subject: December 1987 Guideline
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices page 9
author: FDA / CBER
subject: December 1987 Guideline
4:00 page 17
author: Christine Wildman
Prescription and OTC Drug Product List 1/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 1: Jan 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE ALPROSTADIL TABLET; ORAL INJECTABLE; INJECTION PRECOSE PROSTIN VR PEDIATRIC - DLT - @ BAYER 25MG N20482 004 - DLT - + PHARMACIA AND UPJOHN 0.5MG/ML N18484 001 - DLT - MAY 29, 1997 - ADD -...
Prescription and OTC Drug Product List 2/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 2: February 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CICLOPIROX TABLET; ORAL CREAM; TOPICAL LORTAB LOPROX - DLT - UCB 325MG;5MG N40099 001 - ADD - + AVENTIS PHARMS 0.77% N18748 001 - DLT - JUN 25, 1997 - ADD -...
