first edition (1980) of the Orange Book - FDA Law Blog

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OOTE REXiARDIN:; '!HE USE OF 'lB::mAPIDl'IC mJIVAI.HCE EVAWATIONSDrLg produ:::ts coded AB (or any code lJegiming with an nAn) under an ingredient heading are coosideredtherapeutically equivalent ONIX to other products a:lded AB (or any code beginning with an "A") and NY!' tothose coded BP (or any code begiming with a "B") am anyprodu:::ts not listed. For a canplete explanationof the TE cciles and p:>licies refer to preceding secticns of the Preface.Examples:r Products cx:nsideredTherapeutically EquivalentSULFASALAZINE:TABLET; ORALAZULFIDIHE~----;~ AS PHARMACIA lABS .lli.tl§S.A.S.-5I!O~ ROWELL LABS500MG- SULFASALAz:IHEBP BOLAR PHARHSOONGBP CHELSEA LABSSOONG~~ LEDERLE LABS/AM CYAN 500MGProducts cx:nsidered :ru:rTherapeutically Equivalentto any other product listedor any standard~--:SULFASALAZINEAS~TABLET; ORALAZULFI:DI:HEPHARNACIA LABSS.A.S.-500ROWELL LABSSULJ:ASALAZI:HE500MG500MGBOLAR PHARM SOONG... :: CHELSEA LABSSOONGASLEDERLE LABS/AM CYAN 500MGDICHLORPHENAMIDEProducts cx:nsidered :ru:rTherapeutically Equivalent~ ASto each other., BPTABLET; ORALDARAHIDEMERCK SHARP & DOHMEORATROLALCON LABS50MGSONGNOTE: Bold fent and underlining denotes multisource products which are considered therapeutically. equivalent.
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST1ACETAMINOPHENi ASPIRINi CODEINE PHOSPHATECAPSULE; ORALCODEINE, ASPIRIN, APAPFIRST TEXAS PHARMSCODEINE, ASPIRIN, APAPFIRST TEXAS PHARMSCODEINE, ASPIRIN, APAPFIRST TEXAS PHARMSACETAMINOPHEN; CODEINE PHOSPHATEFORMULA NO. 2150MGi180MGi15MGFORMULA NO. 3150MGi 180MG; 30MGFORMULA NO. 4150MGi180MGi60MGCAPSULE; ORALPHENAPHEN WI CODEINE NO. 2AH ROBINS325MGi15MGPHENAPHEN W/ CODEINE NO.3AA AH ROBINS 3ZSMG;30MGPHENAPHEN WI CODEINE NO. 4AH ROBINS325MGi60MGPROVAL #3AA REID-PROVIDENT LABS 3ZSMG;30MGELIXIR i ORALACETAMINOPHEN W/ CODEINEAA PHILIPS ROXANE LABS lZOMG/SML;lZMG/5MLAPAP W/ CODEINEAA NATL PHARM MFGIBARRE lZOMG/SML;lZMG/5ML-- TYLENOL W/ CODEINEAA MCNEIL LABS lZOMG/SML;lZMG/SMLSUSPENSION; ORALACETAMINOPHEN W/ CODEINE PHOSPHATEAA NATL PHARM MFG/BARRE lZOMG/SML;lZMG/SMLCAPITAL W/ CODEINEAA CARNRICK tABS lZOMG/SML;lZMG/SMLTABLET; ORALACETAMINOPHEN W/ CODEINEAA BARR LABS 300MG;15MG M 300MG;30MGAA LEDERLE LABS/AM CYAN 300MS;30MG ----ACETAMINOPHEN W/ CODEINE NO. ZAA PHILIPS ROXANE LABS 300MS;lSMGACETAMINOFHEN WI CODEINE NO.3AA PHILIPS ROXANE LABS 300MG;30MGACETAMINOPHEN WI CODEINE NO.4AA PHILIPS ROXANE LABS 300MG;60MGACETAMINOPHEN; CODEINE PHOSPHATETABLET; ORALACETAMINOPHEN W/ CODEINE PHOSPHATEAA CARNRICK LABS 3Z5MGt!OMGAA CORD LABS 300MG;60MGAA HALSEY DRUG 300MG;l5MG IE 300MG;30MS IE 300MS;60MGAA HEUN-NORWOOD LABS 3Z5MG;lSMG IE 3ZSMG;30MG M ~;60MG325MGi45MGAA PARKE-DAVIS/W-L 300MG;lSMG IE 300MG;30MGAA PUREPAC PHARM iOOMG;30MG M 300MG;60MGAA TOWNE PAULSEN 300MG;30MG IE 300MG;60MGACETAMINOPHEN W/ CODEINE PHOSPHATE #3AA ZENITH LABS 300MG;30MGACETAMINOPHEN W/ CODEINE PHOSPHATE #4AA ZENITH LABS 300MG;60MGAPAP W/ CODEINE PHOSPHATEAA STAN LABS PHARM 3ZSMG;30MGCAPITAL W/ CODEINEAA CARNRICK LABS 3Z5MG;30MGCODAPCORD LABS325MG;32MGCODEINE PHOSPHATE AND ACETAMINOPHENAA ICN PH ARMS 300MG;30MGEMPRACET W/ CODEINE PHOSPHATE #3AA BURROUGHS WELLCOME 300MG;30MGEMPRACET W/ CODEINE PHOSFHATE #4AA BURROUGHS WELLCOME 300MG;60MGPHENAPHEN-650 WI CODEINEAH ROBINS650MG;30MGTYLENOL W/ CODEINEAA MCNEIL LABS 300MG;15MG M 300MG;30MG IE 300MG;AA 60MG IE 3ZSMG;lSMG IE 3Z5MG;3GMG IEAA !Z5MG;60MG -- -----300MG;7.5MG * 325MG;7.5MGACETAMINOPHEN; HYDROCODONE BITARTRATETABLET; ORALVICODINKNOLL PHARM500MGi5MGACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET; ORALOXYCODONE HCL AND ACETAMINOPHENAA PHILIPS ROXANE LABS 3ZSMG;SMG
Page 5: RXD AND DRUG ACMINISTRATIONAPProVED
Page 9: approved application, a list of app
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