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← Snapshot 21

Orange Book snapshot 21: Products

Products page 83 of 799 · 39,901 matching rows.

Source row, Application type, Application number table
Source rowApplication typeApplication numberProduct numberIngredient rawDosage form / route rawDosage formRouteTrade nameApplicantStrength rawTE rawTE JSONApproval dateApproval date rawApproved before 1982RLDRSProduct typeApplicant full nameRaw row SHA-256
4102A064171001PAROMOMYCIN SULFATECAPSULE;ORALCAPSULEORALPAROMOMYCIN SULFATESUN PHARM INDS INCEQ 250MG BASEAA["AA"]1997-06-30Jun 30, 1997NoNoYesRXSUN PHARMACEUTICAL INDUSTRIES INC5f9828351ad7a00e4404abb8e6c2318f2f9c6b2e1a977ad1b4e3972ab5c59207
4103A207139001PAROXETINE MESYLATECAPSULE;ORALCAPSULEORALPAROXETINE MESYLATEACTAVIS LABS FL INCEQ 7.5MG BASEAB["AB"]2017-06-20Jun 20, 2017NoNoNoRXACTAVIS LABORATORIES FL INCd1f95cce4b29a9b590dbae1c8aa1b3b438af344c08d88d9eddc966bb70996caa
4104A207188001PAROXETINE MESYLATECAPSULE;ORALCAPSULEORALPAROXETINE MESYLATEPRINSTON INCEQ 7.5MG BASEAB["AB"]2017-08-18Aug 18, 2017NoNoNoRXPRINSTON PHARMACEUTICAL INCb7939b95c0695add4c0bc9eccdb481e1ef5529247843ca00e151af8927c08dab
4105N009395004POTASSIUM AMINOSALICYLATECAPSULE;ORALCAPSULEORALPASKALIUMGLENWOOD500MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNGLENWOOD INC019d3f647510a8b63140bc3976ae577c9de16a22adc847bb03334b6b106e5a4b
4106N050011002DICLOXACILLIN SODIUMCAPSULE;ORALCAPSULEORALPATHOCILWYETH AYERSTEQ 250MG BASE[]Approved Prior to Jan 1, 1982YesYesNoDISCNWYETH AYERST LABORATORIES4270ddb2962f542676e77ab069e627e224acbf001d9e3d630d112dd466d06258
4107N050011003DICLOXACILLIN SODIUMCAPSULE;ORALCAPSULEORALPATHOCILWYETH AYERSTEQ 500MG BASE[]1983-03-28Mar 28, 1983NoYesNoDISCNWYETH AYERST LABORATORIESc984bb571937e78856515fe81f7c9bb7ae7debafa8a856143bb661378ce864c2
4108N020885001PAROXETINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALPAXILAPOTEX TECHNOLOGIESEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1998-10-09Oct 9, 1998NoYesNoDISCNAPOTEX TECHNOLOGIES INC8dc18172e663f37ec844b08c1c5a12d26cc8b2e11a6a931a999c8b828dce3c66
4109N020885002PAROXETINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALPAXILAPOTEX TECHNOLOGIESEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1998-10-09Oct 9, 1998NoYesNoDISCNAPOTEX TECHNOLOGIES INC82cad2a51f59cf1170c214a17726fc68ef37e3d778478da456fb83904a63e126
4110N020885003PAROXETINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALPAXILAPOTEX TECHNOLOGIESEQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1998-10-09Oct 9, 1998NoYesNoDISCNAPOTEX TECHNOLOGIES INC66002528a89092b988819620242cc59a363a17a8bc54d44fc7a3438913fe5ad1
4111N020885004PAROXETINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALPAXILAPOTEX TECHNOLOGIESEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1998-10-09Oct 9, 1998NoYesNoDISCNAPOTEX TECHNOLOGIES INC9b5494d55431727089d0390325b0a9d130d5602a2a7251ff85fa348ed5c9a9f4
4112A060908001AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALPENBRITINWYETH AYERSTEQ 250MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNWYETH AYERST LABORATORIES3239843e65f464d248684cda374623a393da09b7dfa9920be2f31de1d8bc766a
4113A060908002AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALPENBRITINWYETH AYERSTEQ 500MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNWYETH AYERST LABORATORIES759488dab305091fc2f46787b8ce0166028dd8a6c6d2cf8d6475aafcd08dbf92
4114A209921001PENICILLAMINECAPSULE;ORALCAPSULEORALPENICILLAMINEANI PHARMS INC250MGAB["AB"]2019-05-07May 7, 2019NoNoNoRXANI PHARMACEUTICALS INC5655d3fb0d22827140a77f1417577e8545509f307b3a8db01b48df2f99e0d788
4115A213310001PENICILLAMINECAPSULE;ORALCAPSULEORALPENICILLAMINEAPOTEX250MGAB["AB"]2020-04-28Apr 28, 2020NoNoNoRXAPOTEX INC619e61e4f4f51ecb921c0a8da7d2b5cbab2a081f73f75e1aff3af0f339931dba
4116A211867001PENICILLAMINECAPSULE;ORALCAPSULEORALPENICILLAMINEDR REDDYS250MGAB["AB"]2020-08-04Aug 4, 2020NoNoNoRXDR REDDYS LABORATORIES LTD952980030cd34f4155e25ab1b75f78b3907b675ef7f891ae8969677c24f9b609
4117A211735001PENICILLAMINECAPSULE;ORALCAPSULEORALPENICILLAMINEGRANULES PHARMS250MGAB["AB"]2020-12-02Dec 2, 2020NoNoNoRXGRANULES PHARMACEUTICALS INC75404a796d503713af857571ac87536675d2359bf377d502d5fca1a69d9eccb0
4118A211231001PENICILLAMINECAPSULE;ORALCAPSULEORALPENICILLAMINEPAR PHARM INC250MGAB["AB"]2019-12-23Dec 23, 2019NoNoNoRXPAR PHARMACEUTICAL INCdf603deac5add20b6d2dbe13159af446dea9b659dfc917c9dc20c175f9f034f0
4119A210976001PENICILLAMINECAPSULE;ORALCAPSULEORALPENICILLAMINEWATSON LABS INC250MGAB["AB"]2019-06-24Jun 24, 2019NoNoNoRXWATSON LABORATORIES INC435c39d8db9416bd048212b4a2f9505e38214cbd803cf3049692f609bc6a0820
4120A085937001PENTOBARBITAL SODIUMCAPSULE;ORALCAPSULEORALPENTOBARBITAL SODIUMLANNETT50MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNLANNETT CO INC7860270ed6eb0c0306acb628e69a0b8a1013ab23970172a0353c74e6644501c8
4121A085915001PENTOBARBITAL SODIUMCAPSULE;ORALCAPSULEORALPENTOBARBITAL SODIUMLANNETT100MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNLANNETT CO INCa6dd28b5b87a1d2111bd913e251c6987d77f6b0965a48fd502c47ea51a027c13
4122A083284001PENTOBARBITAL SODIUMCAPSULE;ORALCAPSULEORALPENTOBARBITAL SODIUMVITARINE100MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNVITARINE PHARMACEUTICALS INC0ed93f7d8bea089289e31bd83e5a51d65dbf87274551d18882d70563ab810c24
4123A083338001PENTOBARBITAL SODIUMCAPSULE;ORALCAPSULEORALPENTOBARBITAL SODIUMWHITEWORTH TOWN PLSN100MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNWHITEWORTH TOWNE PAULSEN INC04b9eb96d3afe84122197041297aa12c0570ab022a654754130ab113045a8821
4124N017551001POTASSIUM PERCHLORATECAPSULE;ORALCAPSULEORALPERCHLORACAPMALLINCKRODT200MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNMALLINCKRODT MEDICAL INCef581d139d0df52b90d1e573710f7b4a01f6081f0860522f7c383ec7e8414555
4125N050744001DOXYCYCLINE HYCLATECAPSULE;ORALCAPSULEORALPERIOSTATCOLLAGENEXEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1998-09-30Sep 30, 1998NoYesNoDISCNCOLLAGENEX INC53ec3a99f4024dbd65d4c88c16c17514217c3ea25f518afa7b0836c046d9c20e
4126N013621001DESIPRAMINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALPERTOFRANESANOFI AVENTIS US25MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNSANOFI AVENTIS US LLCd40ab2c26bee207d2ed086f51929aab0ed3fabe7cd86a81dce1a3d3b804376cb
4127N013621002DESIPRAMINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALPERTOFRANESANOFI AVENTIS US50MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNSANOFI AVENTIS US LLC7d8a073f090533fbf4bf762e53dd6d319e89a1c6efd99e1d58bb743eecb0d6c1
4128A062050001AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALPFIZERPEN-APFIZEREQ 250MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNPFIZER LABORATORIES DIV PFIZER INC2e9735cbad664a18b085d289ea15117d686182f15598933c41bb30319ee2da6b
4129A062050002AMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALCAPSULEORALPFIZERPEN-APFIZEREQ 500MG BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNPFIZER LABORATORIES DIV PFIZER INCbad55f092fdfd22d672b775513b69bb9f2d29a5e5bcb2242c791e7d4091ea05c
4130A084444001ACETAMINOPHEN; CODEINE PHOSPHATECAPSULE;ORALCAPSULEORALPHENAPHEN W/ CODEINE NO. 2ROBINS AH325MG;15MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNAH ROBINS COed57e6bc668f4fe120303c68f938888f8a386ed9078b22dd501522253708c3fb
4131A084445001ACETAMINOPHEN; CODEINE PHOSPHATECAPSULE;ORALCAPSULEORALPHENAPHEN W/ CODEINE NO. 3ROBINS AH325MG;30MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNAH ROBINS CO9968d707cfde4f545be4a0975efb9e8d37d07d9efb01a595763ed13ad9499d06
4132A084446001ACETAMINOPHEN; CODEINE PHOSPHATECAPSULE;ORALCAPSULEORALPHENAPHEN W/ CODEINE NO. 4ROBINS AH325MG;60MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNAH ROBINS CO322189b9b8ecd020136c5d618630dd4b0bd5d96dc257e88e913797a09f59239c
4133A086523001PHENDIMETRAZINE TARTRATECAPSULE;ORALCAPSULEORALPHENAZINEMAST MM35MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNMM MAST AND CO7160555526d69844abbd5eb9025fbb1f1170dcb7afdc8ce6e2d82d43ac6e2a3f
4134A086524001PHENDIMETRAZINE TARTRATECAPSULE;ORALCAPSULEORALPHENAZINEMAST MM35MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNMM MAST AND CO7d7f64bb7f2719f1807d2fbd7c647422a01136cb97e768b67acadf0f2b52f8ca
4135A086525001PHENDIMETRAZINE TARTRATECAPSULE;ORALCAPSULEORALPHENAZINEMAST MM35MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNMM MAST AND COe2ec1a21eb22b39473d2d8319b0c431565ae2a135b5c35c5d5247aaca662cce3
4136A085633001PHENDIMETRAZINE TARTRATECAPSULE;ORALCAPSULEORALPHENDIMETRAZINE TARTRATESANDOZ35MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNSANDOZ INC725df8eb27b9a23012015f8a02810cd0b3346c51a516ba5ea9908d5e2362cc1d
4137A085694001PHENDIMETRAZINE TARTRATECAPSULE;ORALCAPSULEORALPHENDIMETRAZINE TARTRATESANDOZ35MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNSANDOZ INC6fadf320754857d447963ccf78eb6a0368119c4886ca90232e0d4b244085e745
4138A085702001PHENDIMETRAZINE TARTRATECAPSULE;ORALCAPSULEORALPHENDIMETRAZINE TARTRATESANDOZ35MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNSANDOZ INC91ecaf943438b726315d38a8a457c8243f3cf7db09dc9df8a580d5f68c1169b7
4139A085695001PHENDIMETRAZINE TARTRATECAPSULE;ORALCAPSULEORALPHENDIMETRAZINE TARTRATEVIRTUS PHARMS35MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNVIRTUS PHARMACEUTICALS LLC4678ddc5e03f0bcf83c832774173932fa31ec30fc9d6d77358d73640598a80de
4140A085634001PHENDIMETRAZINE TARTRATECAPSULE;ORALCAPSULEORALPHENDIMETRAZINE TARTRATEVITARINE35MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNVITARINE PHARMACEUTICALS INC97cecacdc411eecf2a5c93c2525c46a014afb2317de745201481a764f02561e7
4141A085645001PHENDIMETRAZINE TARTRATECAPSULE;ORALCAPSULEORALPHENDIMETRAZINE TARTRATEVITARINE35MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNVITARINE PHARMACEUTICALS INC8dd3045c55b5ec6d9fe7603a3fb1fbdca034b116677b58a11a35a1bb3fbf721a
4142A085670001PHENDIMETRAZINE TARTRATECAPSULE;ORALCAPSULEORALPHENDIMETRAZINE TARTRATEVITARINE35MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNVITARINE PHARMACEUTICALS INC89e61dd8b15fc52ae2bf100224449e265498f142df467fcfb39e602b0f04c4f4
4143A086403001PHENDIMETRAZINE TARTRATECAPSULE;ORALCAPSULEORALPHENDIMETRAZINE TARTRATEVITARINE35MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNVITARINE PHARMACEUTICALS INC476eb74f20b4e6b3bb005d03be1918e90718adecaabda2973112e5fac9d3d75c
4144A086408001PHENDIMETRAZINE TARTRATECAPSULE;ORALCAPSULEORALPHENDIMETRAZINE TARTRATEVITARINE35MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNVITARINE PHARMACEUTICALS INC629a37cf144f2d8651477b6da0ecea59690ab31bf0648b941c3173c611cf1aa0
4145A086410001PHENDIMETRAZINE TARTRATECAPSULE;ORALCAPSULEORALPHENDIMETRAZINE TARTRATEVITARINE35MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNVITARINE PHARMACEUTICALS INCd1c420bb9f128757de60f3f10c6183673611ec309c1d8b31e7e23e4e0cf1f6d2
4146A087424001PHENDIMETRAZINE TARTRATECAPSULE;ORALCAPSULEORALPHENDIMETRAZINE TARTRATEVITARINE35MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNVITARINE PHARMACEUTICALS INCc13debaae693035a5bfe357793cb4c2204cce5a390439f14a9ee1c56d06c094e
4147A212568001PHENOXYBENZAMINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALPHENOXYBENZAMINE HYDROCHLORIDEAMNEAL10MGAB["AB"]2020-10-27Oct 27, 2020NoNoNoRXAMNEAL EU LTD09a6704b3ff951cf12691bace3c100896848810427741cac7d5a1b0052811055
4148A201050001PHENOXYBENZAMINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALPHENOXYBENZAMINE HYDROCHLORIDEHIKMA10MGAB["AB"]2012-07-16Jul 16, 2012NoNoNoRXHIKMA PHARMACEUTICALS USA INCa34be7e370e9d219bc2838d92cb8ed164536dc01acae8408c3a8389bbf3381a8
4149A204522001PHENOXYBENZAMINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALPHENOXYBENZAMINE HYDROCHLORIDEPAR PHARM INC10MGAB["AB"]2017-01-24Jan 24, 2017NoNoYesRXPAR PHARMACEUTICAL INCc44647a4015840f812c172437cd5f170adca19f7d6025072444ea823f8f09e30
4150A085411001PHENTERMINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALPHENTERMINE HYDROCHLORIDEABC HOLDING30MG[]Approved Prior to Jan 1, 1982YesNoNoDISCNABC HOLDING CORP8d447054b063489bc0618114e2382814ea0e6d3cc5f292493e093be142474816
4151A040497001PHENTERMINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALPHENTERMINE HYDROCHLORIDEABLE15MG[]2003-03-13Mar 13, 2003NoNoNoDISCNABLE LABORATORIES INCa673f7d945b7fc555c8e3bff5e48ef39a52e599c892e587973d3ec36ce3a2491