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  Current Search:  acthrel: 6, corticorelin: 11, ovine: 1058, triflutate: 4  
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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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DDPA May 1996
Drug and Device Product Approvals for May 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 16-191 SORBITRATE ZENECA ISOSORBIDE DINITRATE 01-APR-96 (TABLET, SUBLINGUAL) WILMINGTON, DE 2.5MG (SUPPL-033) 19850 5MG (VASODILATOR) [MET CONDITIONS FOR APPROVAL PER FEDERAL REGISTER NOTICE OF AUGUST 3, 1984 (49 FR 31151)] 16-192 SORBITRATE ZENECA ISOSORBIDE DINITRATE 01-APR-96 ...
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http://www.fda.gov/cder/reports/cderfact.pdf page 24


author: Carolyn Spencer
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http://www.fda.gov/cder/reports/cderfact.pdf
Center for Drug Evaluation and Research fact book 1997 Note: This publication is no longer current
° Performing drug testing and scientific evaluation of drug products in support of the regulatory components of FDA
Total time to approval in months CDER review time in months 21 Pre- User Fee NMEs Approved in 1996 Office of Review Management (cont.) Indications/ Use (general...

author: Carolyn Spencer
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