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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST12ASPIRIN; CAFFEINE; PHENACETIN; PROPOXYPHENE HYDROCHLORIDECAPSULE; ORALPROPOXYPHENE COMPOUND 65AA CORD LABS 227MG;32.5MG;I62MG;65MGAA FEDERAL PHARMACAL 227MG;32.4MG;162MG;65MGAA PARKE-DAVIS/W-L 227MG;32.4MG;162MG;65MGAA PRHfO PHARM LABS 227MG;32.4MG;I62MG;65MGAA PUREPAC PHARM 227MG;32.4MG;162MG;65MGAA TOWNE PAULSEN 227MG;32.4MG;I62MG;65MGAA ZENITH LABS 227MG;32.4MG;162MG;65MGPROPOXYPHENE HCL COMPOUND 65AA PHILIPS ROXANE LABS 227MG;32.4MG;162MG;65MGPROPOXYPHENE HCL WI A.P.C.AA ICN PHARtlS 227MG;32.4MG;I62MG;65MGAA MYLAN PH ARMS 227MG;32.4HG;162MG;65MGAA RICHLYN LABS 227HG;32.4MG;I62MG;65MGREPRO COMPOUND 65AA REID-PROVIDENT LABS 227MG;32.4MG;162MG;65MGSK-65 COMFOUNDAA SKF LABS 227MG;32.4MG;I62MG;65MGASPIRIN; MEPROBAMATETABLET; ORALMICRAININWALLACE PHARMS/C-WASPIRIN; METHOCARBAMOLTABLET; ORALROBAXISALAH ROBINS325MG;200MG325MG;400MGASPIRIN; PENTAZOCINE HYDROCHLORIDETABLET; ORALTALWIN COMPOUNDWINTHROP L/STERLINGASPIRIN; PROPOXYPHENE HYDROCHLORIDECAPSULE; ORALDARVON W/ ASAELI LILLYASPIRIN; PROPOXYPHENE NAPSYLATETABLET; ORALDARVON-N W/ ASAELI LILLYATROPINEINJECTABLE; INJECTIONATROPENSURVIVAL TECHNOLOGY325MG;EQ 12.5MG BASE325MG;65MG325MG;100MGEQ 2MG SULFATE/O.7MLATROPINE SULFATE; DIFENOXIN HYDROCHLORIDETABLET; ORALMOTOFENMCNEIL LABSMOTOFEN HALF-STRENGTHMCNEIL LABS25 UGM;lMG25 UGM;500 UGMASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATETABLET; ORALPER COD ANENDO LABS/DUPONTPERCODAN-DEMIENDO LABS/DUPONT325MG;4.5MGj380 UGM325MG;2.25MG;190 UGMATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDELIQUID; ORALDIPHENOXYLATE HCL AND ATROPINE SULFATEAA WALLACE LABS/C-W 25 UGM/5ML;2.5MG/5MLLOMANATEAA NATL PHARM MFG/BARRE 25 UGM/5ML;2.5MG/5MLLOMOTl:LAA SEARLE 25 UGM/5Ml;2.5MG/5Ml
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST13ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDELIQUID; ORALLOMOXATEAA CORD LABS 25 UGM/5ML;2.5MG/5MLAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAATABLET; ORALOI-ATROMD PHARM 25 UGM;2.5MGOIPHEHOXYLATE HCL AND ATROPIHE SULFATEBARR LABS25 UGM;2.5MGHALSEY DRUG25 UGM;2.5MGHEATHER DRUG 25 UGM;2.5MGINWOOD LABS/FOREST 25 UGM;2.5MGLEDERLE LABS/AM CYAN 25 UGM;2.5MGPHILIPS ROXANE LABS 25 UGM;2.5MGWALLACE LABS/C-W 25 UGH;2.SMGOIPHEHOXYLATE HCL W/ ATROPINE SULFATECHELSEA LABS 25 UGM;2.5HGKV PHARMACEUTICAL 25 UGH;2.SMGMYLAN PHARMS 25 UGM;2.SMGPRIVATE FORMULATIONS 25 UGM;2.5MGZENITH LABS25 UGH;2.5MGOIPHEHOXYLATE W/ ATROPIHE SULFATEGENERIC PHARM/IVY 25 UGM;2.SMGLOFEHElANNETT~;2.SMGLOMOTZLSEARLELOMOXATECORD LABS25 UGM;2.5MG25 UGM;Z.SMGATROPINE SULFATE; MEPERIDINE HYDROCHLORIDEINJECTABLE; INJECTIONMEPERIDINE AND ATROPINE SULFATEWYETH LABS/AMHOAZATADINE MALEATETABLET; ORALOPTIMINESCHERING400 UGM/ML;50MG/ML * 400 UGM/ML;75MG/ML * 400 UGM/ML;IOOMG/MLIMGAZATHIOPRINETABLET; ORALIMURANBURROUGHS WElLCOMEAZATHIOPRINE SODIUMINJECTABLE; INJECTIONlHURANBURROUGHS WELLCOMEAZURESINGRANU.lE; ORALDIAGNEX BLUEER SQUIBB AND SONSBACITRACININJECTABLE; INJECTIONBACZTRACIHAP BRAE LABS/IMCAPAP PFIZER LA.BSAP UPJOHNAPATATATOINTMENT; OPHTHALMICBACIGUEHTUPJOHNBACZTRACIHBYK-GULDENELI LILLY25MG * 50MGEQ 100MG BASE/VIAL2GM/PACKET10,000 UHITS/VIAL *-50,000 UHITS/VIAL50,000 UHZTS/VIAL10.000 UHITS/VIAL *50,000 UHITS/VIAL500 UHITS/GM500 UHZTS/GM500 UNZTS/GHPOWDER; FOR RX COMPOUNDINGBACI-RXAA PHARMA-TEK 5,000,000 UNITS/BOTBACITRACINAA BRAE LABS/IMC 5,000.000 UHITS/BOT
Page 5: RXD AND DRUG ACMINISTRATIONAPProVED
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Page 12 and 13: products that have been approved" i
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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