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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST24CHLORAMPHENICOLADATATATCAPSULE; ORALCHLOROMYCETrHPARKE-DAVIS/W-LMYCHELRACHELLE LABSCREAM; TOPICALCHLOROMYCETINPARKE-DAVIS/W-LINJECTABLE; INJECTIONCH LOROMYCETINPARKE-DAVIS/W-L50MGZ50MGI/,OINTMENT; OPHTHALMICCHLOROMYCETrHPARKE-DAVIS/W-L 1i!CHLOROPTZC S.O.P.ALLERGAN PHARMS 1?ECOt/OCHLORALCON LABS 1?500MG/2MLPOWDER FOR RECONSTITUTION; OPHTHALMICCHLOROMYCETINPARKE-DAVIS/W-L 25MG/VIALSOLUTION; OTICCH LOROMYCETINPARKE-DAVIS/W-L 0.5/.SOLUTION/DROPS; OPHTHALMICCHLOROPTrCAT ALLERGAN PH ARMS 0.5?ECOt/OCHLORAT ALCON LABS 0.5?OPHTHOCHLORAT PARKE-DAVIS/W-L 0.5?CHLORAMPHENICOL SODIUM SUCCINATEINJECTABLE; INJECTIONCHLOROMYCETrHAP PARKE-DAVISIW-LMYCHEL-SAP RACHELLE LABSEQ 100MG 8ASE/MLEQ 100MG 8ASE/MLCHLORAMPHENICOL; DESOXYRIBOHUCLEASE; FIBRINOLYSINOINTMENT; TOPICALELASE WI CHLOROMYCETINPARKE-DAVIS/W-LCHLORAMPHENICOL; POLYMYXIN B SULFATEOINTMENT; OPHTHALMICCHLOROMYXINPARKE-DAVIS/W-LCHLORAMPHENICOL; PREDNISOLONEOINTMENT; OPHTHALMICCHLOROPTIC-P S.O.P.ALLERGAN PHARMSCHLORDIAZEPOXIDETABLET; ORALLIBRITABSROCHE PRODUCTSCHLORDIAZEPOXIDE HYDROCHLORIDElGM/lOOGM;66,666 UNITS/lOOGM;100 UNITS/lOOGM1/.;5,000 UNITS/GMl/.;0.5/.5MG * lOMG * 25MGCAPSULE; ORALCHLORAMPHENICOL PALMITATEA-POXZDEAS ABBOTT LABS 5MG • 10MG • Z5MGSUSPENSION; ORALCHLORDZAZACHELCHLOROMYCETIN PALMITATEAD RACHELLE LABS 5MG • 10MG • ZSMGPARKE-DAVIS/W-l EQ 150MG BASE/5ML CHLORDZAZEPOXZDE HCLAD BARR LABS SMG • 10MG • Z5MG
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST25CHLORDIAZEPOXIDE HYDROCHLORIDECAPSULE; ORALCHLORDIAZEPOXIDE HCLABABCHELSEA LABSCORoD LABSSMG H lOMG H 25MGSMG M lOMG H iSMGABABFEDERAL PHARMACALGENERIC PHARM/IVYSMG H lOMG H 25MGSMG * lOMG H 25MGAB HALSEY DRUG SMG 10MG H 25MGAB LEDERLE LABS/AM CYAN SMG * 10MG M 2SMGAB MK LABS SMG JI 10MG H 2SMGAB MY LAN PHARMS SMG * 10MG H 2SMGAB PARKE-DAVIS/W-L SMG * !Qtl2 H 2SMGAB PHILIPS ROXANE LABS SMG * 10MG H 25MGAB PREMO PHARM LABS SMG * 10MGAB PUREPAC PHARM SMG H 10MG M 2SMGAB RICHLYN LABS SMG * 10MG H25MGAB WEST-WARD 5MG * 10MG H 2SMGAB WESTERN RES LABS SMG * !Qtl2 H 25MGAB ZENITH LABS 5MG M 10MG M 2SMGLIBRIUMAB ROCHE PRODUCTS SMG * 10MG H 2SMGSK-LYGENAB SKF LABS SMG H lOMG H 2SMGINJECTABLE; INJECTIONLIBRIUMHOFFMANN-LA ROCHEIOOMG/AMPCHLORDIAZEPOXIDE; *MULTIPLE*SEE AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDECHLORMERODRIN, HG-I97INJECTABLE; INJECTIONCHLORMERODRIN HG 197ER SQUIBB AND SONSMALLINCKRODTCHLORMEZANONETABLET; ORALCHLORMEZANONEAA BOLAR PHARM ZOOMGTRANCOPALAA BREON LABS/STERLING 200MGIOOMGCHLOROPROCAINE HYDROCHLORIDEINJECTABLE; INJECTIONNESACAINEPENNWALTNESACAINE CEPENNWALTCHLORogUINE HYDROCHLORIDEINJECTABLE; INJECTIONARALEN HCLWINTHROP L/STERLING0.6-I.4MCI/ML500 UCI/MLIX * 2X2X * 3,.EQ 40MG BASE/MLCHLORDIAZEPOXIDE; ESTROGENS, CONJUGATEDTABLET; ORALMENRIUM 10-4HOFFMANN-LA ROCHEMENRIUM 5-2HOFFMANN-LA ROCHEMENRIUM 5-4HOFFMANN-LA ROCHEIOMG;400 UGM5MG;200 UGM5MG;400 UGMAAAAAACHLOROqUINE PHOSPHATETABLET; ORALARALEN PHOSPHATEWINTHROP l/STERLINGCHLOROQUINE PHOSPHATERICHLYN LABSSTAN LABS PHARMWEST-WARDEQ 300MG BASEECj lSOMG BASEECj lSOMG BASEECj lSOMG BASE
Page 5: RXD AND DRUG ACMINISTRATIONAPProVED
Page 9: approved application, a list of app
Page 12 and 13: products that have been approved" i
Page 14 and 15: To assist the user in relating the
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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first edition (1980) of the Orange Book - FDA Law Blog

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