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Pediatric Exclusivity Labeling Changes
Food and Drug Administration • Center for Drug Evaluation and Research Pediatrics Search Pediatric Exclusivity Labeling Changes as of February 6, 2004 - - Exclusivity Granted (Labeled) Product Indications Label Changes 1
2/14/01 (11/16/01) Calcitriol - Calcijex (Abbott) Management of hypocalcemia in patients undergoing chronic renal dialysis The safety 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 Ventolin Albuterol...
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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 CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...

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Reference Listed Drug Labeling Approved in November 2001
Nov 1 COREG letter ---- carvedilol tablets 20-297 S-007 INDERIDE LA letter label propranolol HCl/HCTZ extended-release capsules 19-059 S-016 INDERIDE letter label propranolol HCl/HCTZ tablets 18-031 S-030 Nov 5 TAMIFLU letter label oseltamivir phosphate suspension oseltamivir phosphate capsules 21-246 21-087 S-004 S-009 Nov 7 REGLAN letter label metoclopramide HCl solution...
author: USERNAME
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First-Time Generics - December 2002
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - December 2002 - Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 AMANTADINE HYDROCHLORIDE TABLETS 100 MG UPSHER-SMITH LABORATORIES, INC
SYMMETREL TABLETS 12/16/02 2 DILTIAZEM HYDROCHLORIDE FOR INJECTION 100 MG ADD-VANTAGE VIALS ABBOTT...
author: OGD
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Reference Listed Drug Labeling Approved in April 2000
Tradename Active Ingredient(s) / Dosage Form NDA/Sup# Firm April AMICAR Aminocaproic acid INJ 15-229 030 Immunex 3 AMICAR Aminocaproic acid TAB 15-197 034 Immunex 3 LO/OVRAL Norgestrel/ethinyl estradiol TAB 17-612 031 Wyeth Ayerst 3 NORDETTE-21 Levonorgestrel/ethinyl estradiol TAB 18-668 030 Wyeth Ayerst 3 PREVEN Levonorgestrel/ ethinyl estradiol TAB 20-946 005 Gynetics 3 CALCIJEX...
author: GraceJ
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Abbott to spin-off hospital products business
- Advanced Search - - Business Web sites Thomson Current --Drugs Thomson Delphion Thomson Derwent Thomson ISI Thomson ISI --ResearchSoft Techstreet Thomson --Wila-Derwent - - Current Drugs : E-Bulletin : Abbott to spin-off hospital products business - E-Bulletin Abbott to spin-off hospital products business - Abbott Laboratories, 26 Aug 2003 Abbott Laboratories plans to create a new...
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Prescription and OTC Drug Product List 12/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE TABLET; ORAL PRECOSE -D- BAYER 25MG N20482 004 MAY 29, 1997 DEC CAHN -D- 50MG N20482 001 SEP 06, 1995 DEC CAHN -D- + 100MG N20482 002 SEP 06, 1995 DEC CAHN -A- BAYER PHARMS 25MG N20482 004 MAY 29, 1997 DEC CAHN -A- 50MG N20482 001 SEP 06, 1995 DEC CAHN -A- + 100MG N20482 002 SEP 06, 1995 DEC CAHN ACYCLOVIR -A- CREAM;...
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Medicines, Ethics and Practice page 6


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http://www.fda.gov/cder/foi/appletter/2001/18874s16ltr.pdf
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 NDA 18- 874/ S- 016 Abbott Laboratories Attention: Mary O'Sullivan Associate Director, Regulatory Affairs 16 NOV 2001 Hospital Products Division 200 Abbott Park Road, D- 389 AP30 Abbott Park, IL 60064- 6157 Dear Ms
O'Sullivan: Please refer to your supplemental new drug...

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http://www.fda.gov/cder/foi/appletter/2001/18874s16ltr.pdf page 1


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FDA Drug Approvals List December 1999
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Application # 075406 Approval Date: 15-DEC-99 Trade Name: NORGESTREL AND ETHINYL ESTRADIOL Dosage Form: TABLET Applicant: SCS PHARMACEUTICALS Active Ingredient(s): NORGESTREL; ETHINYL ESTRADIOL OTC/RX Status: RX Original Abbreviated Application # 040262 Approval Date: 15-DEC-99 Trade Name: LEUCOVORIN...
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DDPA October 1995
***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 18-482 PROCARDIA PFIZER LABS NIFEDIPINE 04-OCT-95 (CAPSULE) NEW YORK, NY 10MG 10017 20MG (LABELING REVISION -- DESCRIPTION; CLINICAL PHARMACOLOGY; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; OVERDOSAGE) 19-386 BREVIBLOC OHMEDA PHARM ESMOLOL HYDROCHLORIDE 04-OCT-95 (INJECTABLE) LIBERTY CORNER, NJ 10MG/ML 07938 250MG/ML (LABELING REVISION --...
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Drug Approvals October 1996
Drug Approvals for October 1996 Definitions and Notes October 1996 Original New Drug Applications Original Application #: 019821 Approval Date: 28-OCT-96 Trade Name: SORIATANE Chemical Type: 2 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: HOFFMAN-LAROCHE Active Ingredient(s): ACITRETIN OTC/RX Status: RX Indication(s): Treatment of severe psoriasis Original Application #:...
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Drug Approvals for December 1997
Also provides for the addition of Haemophilus influenzae to the presently approved indication for secondary bacterial infections of acute bronchitis Application #: 020522 Efficacy Supplement#: 004 Type: SE1 to Original New Drug Application Approval Date: 17-DEC-97 Trade Name: NUTROPIN AQ Dosage Form: INJECTABLE Applicant: GENENTECH INC Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC...
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RLD_LABELING_APPROVED_NOV_1999
Acrobat is free and available directly from Adobe's website with full installation instructions TRADENAME ACTIVE/DOSAGE FORM NDA/SUPP# FIRM DEC AMBIEN Zolpidem tartrate/tablet 19-908/S-009 Lorex 1 CALCIJEX Calcitriol/injection 18-874/S-012 Abbott Labs 2 CHIROCAINE Levobupivacaine/injection 20-997/S-001 Darwin Discover 2 PARAPLATIN Carboplatin/for injection 19-880/S-013 Bristol...
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FARMACIE PETRONE S.r.l. - NAPOLI ITALY
FARMACIE PETRONE srl
50 mg, aritmina im iv 1f 2ml 50mg, arlitene 20 conf
10 g, biolac usp scir
200 ui, calcibronat 10 cpr 3 g, calcidon 10 cpr efferv., calcifolin 10 cps 15 mg, calcifolin os 10 fl 15 mg, calcijex iv 25 f 1ml 1mcg ml, calcinil im sc 5 fl 100ui+5f, calcinil im sc 5 fl 50ui+5f, calcio car magn id 100cpr, calcio car magn id 30cpr, calcio car magn id 40cpr,...
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FARMACIE PETRONE S.r.l. - NAPOLI ITALY
FARMACIE PETRONE srl
50 MG, ARITMINA IM IV 1F 2ML 50MG, ARLITENE 20 CONF
10 G, BIOLAC USP SCIR
200 UI, CALCIBRONAT 10 CPR 3 G, CALCIDON 10 CPR EFFERV., CALCIFOLIN 10 CPS 15 MG, CALCIFOLIN OS 10 FL 15 MG, CALCIJEX IV 25 F 1ML 1MCG ML, CALCINIL IM SC 5 FL 100UI+5F, CALCINIL IM SC 5 FL 50UI+5F, CALCIO CAR MAGN ID 100CPR, CALCIO CAR MAGN ID 30CPR, CALCIO CAR MAGN ID 40CPR,...
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Farmacie Petrone Pharmaceuticals Supply
FARMACIE PETRONE srl
50 MG, ARITMINA IM IV 1F 2ML 50MG, ARLITENE 20 CONF
3ML 100, BIOINSULIN R CART 5CART100UI, BIOINSULIN R JET 5 PENNE 3ML, BIOINSULIN U 1 FL 40 U ML, BIOLAC EPS OS 20 BUST
200 UI, CALCIBRONAT 10 CPR 3 G, CALCIDON 10 CPR EFFERV., CALCIFOLIN 10 CPS 15 MG, CALCIFOLIN OS 10 FL 15 MG, CALCIJEX IV 25 F 1ML 1MCG ML, CALCINIL IM SC 5 FL 100UI+5F, CALCINIL IM...
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FARMACIE PETRONE S.r.l. - NAPOLI ITALY
FARMACIE PETRONE srl
50 mg, aritmina im iv 1f 2ml 50mg, arlitene 20 conf
10 g, biolac usp scir
200 ui, calcibronat 10 cpr 3 g, calcidon 10 cpr efferv., calcifolin 10 cps 15 mg, calcifolin os 10 fl 15 mg, calcijex iv 25 f 1ml 1mcg ml, calcinil im sc 5 fl 100ui+5f, calcinil im sc 5 fl 50ui+5f, calcio car magn id 100cpr, calcio car magn id 30cpr, calcio car magn id 40cpr,...
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Farmacie Petrone Pharmaceuticals Supply
FARMACIE PETRONE srl
200 UI, CALCIBRONAT 10 CPR 3 G, CALCIDON 10 CPR EFFERV., CALCIFOLIN 10 CPS 15 MG, CALCIFOLIN OS 10 FL 15 MG, CALCIJEX IV 25 F 1ML 1MCG ML, CALCINIL IM SC 5 FL 100UI+5F, CALCINIL IM SC 5 FL 50UI+5F, CALCIO CAR MAGN ID 100CPR, CALCIO CAR MAGN ID 30CPR, CALCIO CAR MAGN ID 40CPR, CALCIO CLORURO 0+5MEQ 5F10ML, CALCIO CLORURO 1G 5F 10ML, CALCIO CLORURO 1G 6F...
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Farmacie Petrone Pharmaceuticals Supply
FARMACIE PETRONE srl
200 ui, calcibronat 10 cpr 3 g, calcidon 10 cpr efferv., calcifolin 10 cps 15 mg, calcifolin os 10 fl 15 mg, calcijex iv 25 f 1ml 1mcg ml, calcinil im sc 5 fl 100ui+5f, calcinil im sc 5 fl 50ui+5f, calcio car magn id 100cpr, calcio car magn id 30cpr, calcio car magn id 40cpr, calcio cloruro 0+5meq 5f10ml, calcio cloruro 1g 5f 10ml, calcio cloruro 1g 6f...
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