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http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL ...
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TYLOX PI
TYLOX ® (oxycodone and acetaminophen capsules USP) Analgesic C II For Oral Use Prescribing Information DESCRIPTION Each capsule of TYLOX (oxycodone and acetaminophen capsules USP) contains: Oxycodone Hydrochloride USP.......
The principal actions of therapeutic value of the oxycodone in TYLOX (oxycodone and acetaminophen...
author: Donna s Madhouse
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
PROPARACAINE HCL 2712 03-Aug-76 PHARMACIA AND UPJOHN INC "HEPARIN, SODIUM U.S.P." 2716 10-Aug-76 SMITHKLINE CORP "CIMETIDINE AND CIMETIDINE HCL MANUFACTURED IN CORK, IRELAND." 2719 09-Aug-76 PLANTEX LTD CHEM AND PHARM WORKS AMITRIPTYLINE HCL 2726 05-Aug-76 SCHERING AG NORETHINDRONE 2736 19-Jul-76 ROUSSEL-UCLAF "DEXAMETHASONE ACETATE ANHYDROUS USP MANUFACTURED IN VERTOLAYE, FRANCE."...
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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
3M PHARMS CORDRAN (FLURANDRENOLIDE) TAPE ORGANICS DIV LA GRANGE INC ESTERIFIED ESTROGENS USP POWDER ORGANICS DIV LA GRANGE INC CONJUGATED ESTROGEN USP POWDER GANES CHEMICALS INC PROPOXYPHENE HYDROCHLORIDE AVENTIS PHARMA SA HYDROCORTISONE USP MALLINCKRODT INC OXYCODONE TEREPHTHALATE SOLMAG S.P.A CLIDINIUM BROMIDE PLIVA PHARMACEUTICAL CHEMICAL FOOD & COSMETIC INDUSTRY...
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OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004
- TABLET/CAPSULES; ORAL Denied 3/1/2001- NALTREXONE HYDROCHLORIDE 25MG, 100MG & 150MG - 99P-4775/CP1 LACHMAN CONSULTANT SERVICES - TABLET; ORAL Approved 4/13/2000- CEFAZOLIN SODIUM, STERILE 100 G & 300 G - 99P-4870/CP1 QUINN CONSULTING SERVICES - FOR INJECTION Approved 4/12/2002- CEFUROXIME SODIUM, STERILE 75 G & 225 G - 99P-4871/CP1 QUINN CONSULTING SERVICES - FOR INJECTION...
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OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004
- TABLET; ORAL, CAPSULE;ORAL Approved 4/14/2000- ACETAMINOPHEN 770 MG, 385 MG CAFFEINE 60 MG, 30 MG - 03P-0505/CP1 LACHMAN CONSULTANT SERVICES - TABLET Approved - ACETAMINOPHEN; 320 MG/10 ML HYDROCODONE BITARTRATE 10 MG/10 ML - 01P-0130/CP2 PHARMACEUTICAL ASSOCIATES, INC - SOLUTION; ORAL Denied 7/9/2002- ACETAMINOPHEN; 325 MG & 500MG/15 ML HYDROCODONE BITARTRATE 10...
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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...
author: AUTHOR
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Prescription and OTC Drug Product List 10/2001
PEDIATRIC -D- + ASTRAZENECA 80MG/VIAL;0.02MG/VIAL;0.00 1MG/VIAL;5MG/VIAL;0.01MG/V IAL;0.14MG/VIAL;17MG/VIAL; 0.2MG/VIAL;1MG/VIAL;1.4MG/ VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/V IAL N18920 001 SEP 21, 2000 OCT CAHN -A- + NEOSAN PHARMS 80MG/VIAL;0.02MG/VIAL;0.00 1MG/VIAL;5MG/VIAL;0.01MG/V IAL;0.14MG/VIAL;17MG/VIAL; 0.2MG/VIAL;1MG/VIAL;1.4MG/ VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/V IAL...
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Prescription and OTC Drug Product List 7/1998
Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 7: July 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE - ADD - CALFACTANT TABLET; ORAL - ADD - INJECTABLE; INJECTION BUTALBITAL,ACETAMINOPHEN AND CAFFEINE - ADD - INFASURF PRESERVATIVE FREE - ADD - AB + MIKART...
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FDA Drug Approvals List- February 1998
Drug Approvals for February 1998 Definitions and Notes February 1998 Original New Drug Applications Original Application #: 050750 Approval Date: 24-FEB-98 Trade Name: ZOSYN Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: LEDERLE PIPERACILLIN INC DIV AMERICAN CYANAMID CO Active Ingredient(s): PIPERACILLIN SODIUM; TAZOBACTAM SODIUM OTC/RX Status: RX...
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Oxycodone - [Medication] - Quest Diagnostics Patient Health Library
Oxycodone Examples Brand Name Chemical Name OxyContin, OxyFAST, OxyIR, Percolone, Roxicodone, Intensol Oxycodone hydrochloride Endocet, Oxycocet, Percocet, Percocet 2.5/325, 5/325, and 7.5/500, Percocet-Demi, Roxicet, Tylox Oxycodone and acetaminophen Endodan, Percodan Oxycodone and aspirin Oxycodone is available as pills, controlled-release...
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GAO-04-110, PRESCRIPTION DRUGS: OxyContin Abuse and Diversion and Efforts to Address the Problem
Page i GAO- 04- 110 OxyContin Abuse and Diversion Letter 1 Results in Brief 4 Background 7 Purdue Conducted an Extensive Campaign to Market and Promote OxyContin 16 Several Factors May Have Contributed to OxyContin Abuse and Diversion, but Relationship to Availability Cannot Be Assessed 29 Federal and State Agencies and Purdue Have Taken Actions to Prevent Abuse and Diversion of...
author: U.S. General Accounting Office, http://www.gao.gov
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Drug Testing Quarterly - Winter 2003
- [ Certification ] [Drug Facts] [ Frequently Asked Questions ] [ In the News ] - Drug Facts Oxycodone Classification: Opiate-narcotic analgesic Background The milky residue collected from the opium poppy plant (opium) is the natural material from which opiate compounds are extracted or synthesized
Oxycodone is a semi-synthetic opiate derived from opium
Oxycodone...
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Norchem Oxycodone Fact Sheet
URINE DRUG TEST FACT SHEET OXYCODONE Classification: Opiate-narcotic analgesic Background: The milky residue collected from the opium poppy plant (opium) is the natural material from which opiate compounds are extracted or synthesized
Oxycodone, like other opiates is characterized by its analgesic properties, and the tendency for users to form a physical dependency and...
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Norchem Opiates Fact Sheet
URINE DRUG TEST FACT SHEET OPIATES [ Heroin ] [ Morphine ] [ Codeine ] [ Hydrocodone ] [ Hydromorphone ] [ Oxycodone ] Classification: Narcotics Background: The terms -narcotics- and -opiates- are often used interchangeably but are not exactly the same
Drug Trade Name* Class Legal Use* Buprenorphine Buprenex Opiate narcotic Pain relief Butorphanol Stadol Opiate narcotic Pain...
author: indigo8 - http://www.indigo8.com
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http://www.fda.gov/cder/foi/appletter/2000/40304ltr.pdf
ANDA 40- 304 October 2, 2000 Barr Laboratories, Inc
Box 2900 Pomona, NY 10970 Dear Madam: This is in reference to your abbreviated new drug application dated March 26, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Oxycodone and Acetaminophen Capsules USP, 5 mg/ 500 mg, respectively
We have completed the review of...
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http://www.fda.gov/cder/foi/appletter/2000/40304ltr.pdf page 1
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H: 57.PDF
ANDA 40- 257 August 4, 1998 Mallinckrodt Chemical, Inc
Attention: Marianne Robb 16305 Swingley Ridge Drive Chesterfield, MO 63017 Dear Madam: This is in reference to your abbreviated new drug application dated June 30, 1997, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Oxycodone and Acetaminophen Capsules USP, 5 mg/ 500 mg
author: Unknown
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H: 57.PDF page 1
author: Unknown
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http://www.endo.com/generics/factsheets/Oxycodone.pdf
TAKING BROKEN, CHEWED, OR CRUSHED OXYCODONE HYDROCHLORIDE EXTENDEDRELEASE TABLETS LEADS TO RA RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.
OXYCODONE HYDROCHLORIDE EXTENDED- RELEASE TABLETS 10 mg, 20 mg, 40 mg, 80 mg 80 mg FOR USE IN OPIOID- TOLERANT PATIENTS ONLY Brief Summary (For full Prescribing Information and Patient...
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http://www.endo.com/generics/factsheets/Oxycodone.pdf page 2
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Drug Approvals - O
ANDA 75-923 7/31/02 Oxycodone and Acetaminophen Capsules, 5 mg/500 mg, Rx Barr Laboratories ANDA 40-304 10/2/00 10/30/00 - - Oxycodone and Acetaminophen Capsules, 5 mg/500 mg, Rx Amide Pharmaceuticals ANDA 40-199 12/30/98 - - 8/1/03 Oxycodone and Acetaminophen Capsules USP,5 mg/500 mg
ANDA 40-303 12/30/99 1/3/00 - 8/4/03 Oxycodone and ...
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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...
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Prescription and Over-the-Counter Drug Product List: 12/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429 001 SEP 10,...
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Prescription and Over-the-Counter Drug Product List: 10/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML N40520 001 OCT 30, 2003 OCT NEWA TABLET; ORAL ANEXSIA >D> AA MALLINCKRODT 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA >A> AA 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA ALBUTEROL...
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