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 HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
TEMAZEPAM 4381 14-Sep-81 DINAMITE DIPHARMA SPA METOCLOPRAMIDE HYDROCHLORIDE BP'80 4395 25-Nov-81 DANISCO INGREDIENTS BUTALBITAL 4397 22-Dec-81 HOVIONE SOCIEDADE QUIMICA LDA BETAMETHASONE 17-VALERATE 4416 23-Jan-82 LABORATORIO CHIMICO INTERNATIONAL SPA CARISOPRODOL 4420 03-Feb-82 SOCIETA ITALIANA CORTICOSTEROIDI SPA DESONIDE 4423 03-Feb-82 AVENTIS PHARMA SA FLUOROMETHOLONE...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
URSODEOXYCHOLIC ACID MEDIMPEX INC ALPHA METHYLDOPA USP XIX BULK AS MFG BY EGIS PHARMACEUT WORKS BUDAPEST ACRAF TRAZODONE HCL ROCHE COLORADO CORPORATION BUTOCONAZOLE NITRATE GEDEON RICHTER LTD NORETHISTERONE DINAMITE DIPHARMA SPA FUROSEMIDE USP SCHERING AG ESTRADIOL-VALERATE SCHERING AG TESTOSTERONE ENANTHATE PROQUINA SA PIPERAZINE ESTRONE SULFATE MERCK AG METHYL GLUCAMINE ...
Alefacept (Amevive) Clinical Review page 26
author: CBER FDA
subject: dob062703
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...
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Phone: 800 375-2179 / 765 463-0112 Fax: 765 497-2649 / 765 463-4722 E-mail: info@ssci-inc.com SSCI Inc., 3065 Kent Avenue, West Lafayette, IN 47906 - 1076 USA Acetaminophen Acetazolamide Acetohexamide Acetylcysteine Acyclovir Adenine L-Alanine Albuterol Albuterol Sulfate Allopurinol Alprazolam Amantadine HCl Amiloride HCl Aminobenzoic Acid Aminoglutethimide Aminosalicylic Acid...
author: SSCI Webmaster
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FDA Drug Approvals List- February 1999
Applicant: CONNETICS CORP Active Ingredient(s): BETAMETHASONE VALERATE OTC/RX Status: RX Indication(s):For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp Original Application #: 020969 Approval Date: 25-FEB-99 Trade Name: UVADEX Chemical Type: 3 Therapeutic Potential: S Dosage Form: SOLUTION Applicant:...
http://www.raps.org/pdf/ac/2001/Johnston_G_505b2_NDA_Tues_800.pdf
The 505( b)( 2) NDA: What Is It & How Do You Use It RAPS 2001 Annual Conference Baltimore, Maryland November 4- 7, 2001 Gordon Johnston, M. S., R. Ph. Lachman Consultant Services, Inc. ...
FDA Drug Approvals List November 2000
Active Ingredient(s): VINORELBINE TARTRATE OTC/RX Status: RX Application #: 018936 Labeling Supplement #: 063 To Original New Drug Application Approval Date: 28-NOV-00 Trade Name: PROZAC Dosage Form: CAPSULE Applicant: LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO Active Ingredient(s): FLUOXETINE HYDROCHLORIDE OTC/RX Status: RX Application #: 018936 Labeling Supplement #: 062 To...