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  Current Search:  klor: 55, con: 18539, m20: 208, potassium: 14090, chloride: 7743  
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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, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...

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Drug Approvals - K
Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Kaletra (lopinavir) oral solution, 80mg lopinavir/20mg ritonavir
Kanamycin Injection USP, 500 mg/2 mL & 1 g/3 mL, Rx American Pharmaceutical Partners, Inc
NDA 21-035/S13 & S19 5/22/02 5/29/0 2 - - Keppra (levetiracetam)- Tablets, 250 mg, 500 mg, and 750 mg
ANDA 75-597 12/23/99 12/23/99 ...
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1997 Abbreviated New Drug Applications (Generic Drugs)
Generic Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
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/Actuation
64155, 64164, 64165, 64166 10/2/1997...
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Prescription and OTC Drug Product List 11/1998
Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 11: November 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CLOBETASOL PROPIONATE TABLET; ORAL OINTMENT; TOPICAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN EMBELINE - ADD - ENDO PHARMS 400MG;5MG N40288 001 - ADD - AB...
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FDA Drug Approvals List
Active Ingredient(s): NEDOCROMIL SODIUM OTC/RX Status: RX Efficacy Claim: Extending the approved use to the pediatric population of 6-11 years of age Approvable Original New Drug Applications Original Application #: 019781 Approvable Date: 31-MAR-97 Trade Name: PROMETRIUM Dosage Form: CAPSULE Applicant: SCHERING PLOUGH CORP Active Ingredient(s): PROGESTERONE OTC/RX Status: RX...
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H: 26AP.PDF page 1


author: Unknown
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Prescription and Over-the-Counter Drug Product List: 6/2003
>D> AP + WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC >A> @ 5,000 UNITS/VIAL N17055 001 JUN DISC >D> AP + 10,000 UNITS/VIAL N17055 002 JUN DISC >A> @ 10,000 UNITS/VIAL N17055 002 JUN DISC GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE >D> AB WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >A> AB + EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >D> WYTENSIN >D> AB WYETH...
author: AUTHOR
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Microsoft PowerPoint - FTC - Markus Meier [Read-Only]
THE FTC's PHARMACEUTICAL CASES Markus H
A22 Acquisitions of Exclusives to Related Patents ° Brand acquires an exclusive license to a related patent ° The newly acquired patent may delay generic entry or prevent competition by others ° Can be problematic where brand already possesses significant market power FTC's "Exclusive License Cases" ° Lilly/ Sepracor...

author: Pamela Putz
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Microsoft PowerPoint - FTC - Markus Meier [Read-Only] page 34


author: Pamela Putz
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C:\Data\My Documents\Letters 2003\19123s021ap.doc page 1


author: Daryl L. Allis
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