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,...
Drug Approvals - K Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Kaletra (lopinavir) oral solution, 80mg lopinavir/20mg ritonavir
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
Prescription and Over-the-Counter Drug Product List: 11/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST >A> ABARELIX >A> INJECTABLE; INTRAMUSCULAR >A> PLENAXIS >A> + PRAECIS 100MG/VIAL N21320 001 NOV 25, 2003 NOV NEWA ALBUTEROL SULFATE SOLUTION; INHALATION ALBUTEROL SULFATE >A> AN BREATH LTD EQ 0.083% BASE N76370 001 NOV 24, 2003 NOV NEWA BACLOFEN TABLET, ORALLY DISINTEGRATING; ORAL KEMSTRO >D> SCHWARZ PHARMA 10MG...
C:\Wheelous\NDA\21589 Baclofen ODT\Approval Letter.doc NDA 21- 589 Page 5 KEMSTRO (baclofen orally disintegrating tablets) Rx Only DESCRIPTION KEMSTRO (baclofen orally disintegrating tablets) is a muscle relaxant and antispasticKEMSTRO ™ given with or without water is bioequivalent to the baclofen conventional tabletKEMSTRO is not indicated in the treatment of skeletal muscle spasm...
author: Teresa Wheelous
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author: Teresa Wheelous
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author: Teresa Wheelous
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author: Teresa Wheelous
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author: Teresa Wheelous
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author: Teresa Wheelous
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author: Teresa Wheelous
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author: Teresa Wheelous
