← Snapshot 21

Orange Book snapshot 21: Products

Products page 31 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
1502A206261001ACYCLOVIRCAPSULE;ORALCAPSULEORALACYCLOVIRCARLSBAD TECHNOLOGY200MGAB["AB"]2017-08-16Aug 16, 2017NoNoNoRXCARLSBAD TECHNOLOGY INC169d4ccd9f780d850cfeeef1a465e532793411cb94053ab84ab28abb7b431306
1503A074872001ACYCLOVIRCAPSULE;ORALCAPSULEORALACYCLOVIRCHARTWELL MOLECULES200MG[]1997-04-22Apr 22, 1997NoNoNoDISCNCHARTWELL MOLECULES LLCdb40a6eee679fb14d720cab243aa110d1408e1fc502a81ba100ff3e0ecb7d7ba
1504A074833001ACYCLOVIRCAPSULE;ORALCAPSULEORALACYCLOVIRDAVA PHARMS INC200MG[]1997-04-22Apr 22, 1997NoNoNoDISCNDAVA PHARMACEUTICALS INC29e90b00bacc9a8d0c4cff87a97e8e451dc03f1d580431386431fdfae6d0285c
1505A074889001ACYCLOVIRCAPSULE;ORALCAPSULEORALACYCLOVIRHERITAGE PHARMS INC200MGAB["AB"]1997-10-31Oct 31, 1997NoNoNoRXHERITAGE PHARMACEUTICALS INC93b33c50355c5e3d7c3e40f59e2c61abb45f575589d029bd3b7672e5ed2d46cd
1506A074674001ACYCLOVIRCAPSULE;ORALCAPSULEORALACYCLOVIRIVAX SUB TEVA PHARMS200MG[]1997-04-22Apr 22, 1997NoNoNoDISCNIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA0d9788304b6ae06b1e84e727efe58a24c5c139b5bc0dcc284ffe4e8c84f4ce5c
1507A075090001ACYCLOVIRCAPSULE;ORALCAPSULEORALACYCLOVIRKENTON200MGAB["AB"]1999-01-26Jan 26, 1999NoNoNoRXKENTON CHEMICALS AND PHARMACEUTICALS CORP438dd34fdfc51ef2cb7ee21a5b960ec9bc7db532442074beeded1cf2af6e6e18
1508A074750001ACYCLOVIRCAPSULE;ORALCAPSULEORALACYCLOVIRLEK PHARM200MG[]1997-04-22Apr 22, 1997NoNoNoDISCNLEK PHARMACEUTICAL AND CHEMICAL CO DDa6db56c16fcad84863767df605af674798156086df405adc2520cb4954d912e6
1509A074727001ACYCLOVIRCAPSULE;ORALCAPSULEORALACYCLOVIRMYLAN200MG[]1997-04-22Apr 22, 1997NoNoNoDISCNMYLAN PHARMACEUTICALS INCf83452b32e90c1cc13d3ac1cc5112312976f9465b3f8b2934db47453e83b592f
1510A074977001ACYCLOVIRCAPSULE;ORALCAPSULEORALACYCLOVIRMYLAN200MG[]1998-04-13Apr 13, 1998NoNoNoDISCNMYLAN PHARMACEUTICALS INC7ad3a7dd73e7241a41a0dbf4d906e9b2ff110437628ce0caf44c7413b4a0d649
1511A074975001ACYCLOVIRCAPSULE;ORALCAPSULEORALACYCLOVIRRANBAXY200MG[]1998-09-30Sep 30, 1998NoNoNoDISCNRANBAXY LABORATORIES LTDfc2bdf89bd6ffd0ef604eb6b8bed15912c9e806b62a821ad6a6e123af55ba631
1512A074570002ACYCLOVIRCAPSULE;ORALCAPSULEORALACYCLOVIRROXANE200MG[]1997-04-22Apr 22, 1997NoNoNoDISCNROXANE LABORATORIES INCf10fff42261386de172b48113aa45d35c13fd73abfddd280af9d67424f642a23
1513A074578001ACYCLOVIRCAPSULE;ORALCAPSULEORALACYCLOVIRTEVA200MGAB["AB"]1997-04-22Apr 22, 1997NoNoNoRXTEVA PHARMACEUTICALS USA INC964dbd1275e3dae9ec3e235de179676e49924fdbe11bf816e7dc192493dfffb8
1514A074828001ACYCLOVIRCAPSULE;ORALCAPSULEORALACYCLOVIRTEVA200MG[]1997-04-22Apr 22, 1997NoNoNoDISCNTEVA PHARMACEUTICALS USA INCea1a6f78bcb3db7e918e0306bb60201ef579e50f4e42a1d0de3f55e84625e991
1515A074914001ACYCLOVIRCAPSULE;ORALCAPSULEORALACYCLOVIRTEVA PHARMS200MG[]1997-11-26Nov 26, 1997NoNoNoDISCNTEVA PHARMACEUTICALS USA585638c4fc1671f72f838b3b1e94e3f78de8003e68df0a863919c0be2701bffb
1516A075101001ACYCLOVIRCAPSULE;ORALCAPSULEORALACYCLOVIRWATSON LABS200MG[]1998-04-15Apr 15, 1998NoNoNoDISCNWATSON LABORATORIES INC3a133b01cb48307af8c287c87ab463e4d1896679700b14ddf93838df743dc19a
1517A212173001ACYCLOVIRCAPSULE;ORALCAPSULEORALACYCLOVIRYILING200MGAB["AB"]2020-09-14Sep 14, 2020NoNoNoRXYILING PHARMACEUTICAL LTD2da415115acc2fc0e46546809f1ceeefa89a05476c73618a6c4ab156786ac365
1518N019478001NIFEDIPINECAPSULE;ORALCAPSULEORALADALATBAYER PHARMS10MG[]1985-11-27Nov 27, 1985NoNoNoDISCNBAYER PHARMACEUTICALS CORP06f93692341451439312db8e7a2213545ba2d807c7c1921cba4bcadda4442507
1519N019478002NIFEDIPINECAPSULE;ORALCAPSULEORALADALATBAYER PHARMS20MG[]1986-09-17Sep 17, 1986NoNoNoDISCNBAYER PHARMACEUTICALS CORP80c8640167235e360985021c5409fb76fd11326741c949c8bb3de6b5defa0300
1520A088023001PHENTERMINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALADIPEX-PTEVA37.5MGAA["AA"]1983-08-02Aug 2, 1983NoNoYesRXTEVA PHARMACEUTICALS USA INC1960ac3be71c6c678b7cd8b05ecc94edf0c2e9999cf558114582a1cc0383d190
1521N021374001IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALADVIL COLD AND SINUSGLAXOSMITHKLINEEQ 200MG FREE ACID AND POTASSIUM SALT;30MG[]2002-05-30May 30, 2002NoYesYesOTCGLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS US LLC021c73f41152bbd35efd3bc291dae4701b680d10c6395d4a1d732d692166cfb8
1522N020402001IBUPROFENCAPSULE;ORALCAPSULEORALADVIL LIQUI-GELSGLAXOSMITHKLINEEQ 200MG FREE ACID AND POTASSIUM SALT[]1995-04-20Apr 20, 1995NoYesYesOTCGLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS US LLC770c5aede2820f2c2ff742b9584118c7ec0f56bc31cee73b2d870fc54dd3ddae
1523N020402002IBUPROFENCAPSULE;ORALCAPSULEORALADVIL MIGRAINE LIQUI-GELSGLAXOSMITHKLINEEQ 200MG FREE ACID AND POTASSIUM SALT[]2000-03-16Mar 16, 2000NoYesYesOTCGLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS US LLC2a841673b3f3b0117963cf69f9e721e25cb1b7496fda319e68f9c274f065144b
1524N021393001DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFENCAPSULE;ORALCAPSULEORALADVIL PMGLAXOSMITHKLINE25MG;EQ 200MG FREE ACID AND POTASSIUM SALT[]2005-12-21Dec 21, 2005NoYesYesOTCGLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS US LLC2a0cdf4600028315cfcc4d6622815a5ad9ae2c1834dbdbdb2529f076c0326736
1525A083187001VITAMIN A PALMITATECAPSULE;ORALCAPSULEORALAFAXINSTERLING WINTHROPEQ 50,000 UNITS BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNSTERLING WINTHROP INC922e72c9164fee3ac3d9ff57b6dc3858518db940dbb3882dc386057b84c55e65
1526N021007001AMPRENAVIRCAPSULE;ORALCAPSULEORALAGENERASEGLAXOSMITHKLINE50MG[]1999-04-15Apr 15, 1999NoNoNoDISCNGLAXOSMITHKLINEb5b3e5757b030a6a0b93515512568d9d9263bbb9d2c435396f124569ec946566
1527N021007002AMPRENAVIRCAPSULE;ORALCAPSULEORALAGENERASEGLAXOSMITHKLINE150MG[]1999-04-15Apr 15, 1999NoNoNoDISCNGLAXOSMITHKLINEd5e449a9af7a2ca7c79af36be71f8b02b29ebdf11a3207e2420dd8710ed46618
1528N020333001ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAGRYLINTAKEDA PHARMS USAEQ 0.5MG BASEAB["AB"]1997-03-14Mar 14, 1997NoNoNoRXTAKEDA PHARMACEUTICALS USA INC41eaf3a4617877805385c1a1183f2a1de580593682520591c69fc6815c02d6b5
1529N020333002ANAGRELIDE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAGRYLINTAKEDA PHARMS USAEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1997-03-14Mar 14, 1997NoYesNoDISCNTAKEDA PHARMACEUTICALS USA INCdebdf7f6e708e802abe9d4f3b3812b09086c641aa5c47e214aa77b1d3c73e03a
1530N205718001NETUPITANT; PALONOSETRON HYDROCHLORIDECAPSULE;ORALCAPSULEORALAKYNZEOHELSINN HLTHCARE300MG;EQ 0.5MG BASE[]2014-10-10Oct 10, 2014NoYesYesRXHELSINN HEALTHCARE SA263805472d3c3f71ded6262b198b89b768c59895aee00d4c505a02aadd333d51
1531N208434001ALECTINIB HYDROCHLORIDECAPSULE;ORALCAPSULEORALALECENSAHOFFMANN-LA ROCHEEQ 150MG BASE[]2015-12-11Dec 11, 2015NoYesYesRXHOFFMANN-LA ROCHE INC3e633a8152229e3ac8580732be6add617e225e2e82c1b09b9e75f3ca937ba5da
1532A089907001ACETAMINOPHEN; HYDROCODONE BITARTRATECAPSULE;ORALCAPSULEORALALLAYIVAX PHARMS500MG;5MG[]1989-01-13Jan 13, 1989NoNoNoDISCNIVAX PHARMACEUTICALS INC36294a4b630a11f636783840c40e1865c7f486c7a141e3538bc9445016a621c5
1533N020625001FEXOFENADINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALALLEGRASANOFI AVENTIS US60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]1996-07-25Jul 25, 1996NoNoNoDISCNSANOFI AVENTIS US LLCa857ed7198e1063fcdd5c8dd0391c2e2a03fcd6ff7e8ac658c1060919ee02c5d
1534N021887001ORLISTATCAPSULE;ORALCAPSULEORALALLIGLAXOSMITHKLINE CONS60MG[]2007-02-07Feb 7, 2007NoYesYesOTCGLAXOSMITHKLINE CONSUMER HEALTHCAREf71a5264d939cc876c0f30ca388af36ec28a397dc609dc4da960156c12177561
1535N022233001PALONOSETRON HYDROCHLORIDECAPSULE;ORALCAPSULEORALALOXIHELSINN HLTHCAREEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**[]2008-08-22Aug 22, 2008NoYesNoDISCNHELSINN HEALTHCARE SA5e6a63918c55c5f674faef6fd55e917aed9894f6b582256ba1d092bad5db8ba2
1536A080883001VITAMIN A PALMITATECAPSULE;ORALCAPSULEORALALPHALINLILLYEQ 50,000 UNITS BASE[]Approved Prior to Jan 1, 1982YesNoNoDISCNELI LILLY AND COcb981204b79c860951f01f3cccec4a2b20a4bf58814e2858284edef46a44fa5b
1537N019901001RAMIPRILCAPSULE;ORALCAPSULEORALALTACEKING PHARMS LLC1.25MGAB["AB"]1991-01-28Jan 28, 1991NoYesNoRXKING PHARMACEUTICALS LLC53b9a020bcf0efcabff967eac010cd405d89a92ffa58e418fea4479d81e5716f
1538N019901002RAMIPRILCAPSULE;ORALCAPSULEORALALTACEKING PHARMS LLC2.5MGAB["AB"]1991-01-28Jan 28, 1991NoYesNoRXKING PHARMACEUTICALS LLCec946b53e52a950b136f33af6ca3ff4d04ebe44e86424817aeaa3c44490c6ad7
1539N019901003RAMIPRILCAPSULE;ORALCAPSULEORALALTACEKING PHARMS LLC5MGAB["AB"]1991-01-28Jan 28, 1991NoYesNoRXKING PHARMACEUTICALS LLCa07661c7602a98c400f187cbfe1695930233e6f38fb1692b0c122459c8640ea4
1540N019901004RAMIPRILCAPSULE;ORALCAPSULEORALALTACEKING PHARMS LLC10MGAB["AB"]1991-01-28Jan 28, 1991NoYesYesRXKING PHARMACEUTICALS LLCedc4e851a6418ccb0d8ef3522667aa55fa87260fd19956c29cf6bf9a920f920a
1541A208295001ALVIMOPANCAPSULE;ORALCAPSULEORALALVIMOPANWATSON LABS TEVA12MGAB["AB"]2019-12-19Dec 19, 2019NoNoNoRXWATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC29de8ff59d7fd50c1a2d20c4a58d09798388dad97563f1c6c5dd7953e22861a0
1542A077659001AMANTADINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMANTADINE HYDROCHLORIDEACTAVIS ELIZABETH100MG[]2006-02-23Feb 23, 2006NoNoNoDISCNACTAVIS ELIZABETH LLC2a2d1771608065c0e5e536ddefb8f3504500d50dc4da6d09fe61a6a05d82b5d3
1543A208966001AMANTADINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMANTADINE HYDROCHLORIDEALEMBIC PHARMS LTD100MGAB["AB"]2017-06-21Jun 21, 2017NoNoNoRXALEMBIC PHARMACEUTICALS LTD84119f62392daf9331ac11517be2dfc80e0d027a5f5407859c8359566ab787cb
1544A078720001AMANTADINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMANTADINE HYDROCHLORIDEBIONPHARMA INC100MGAB["AB"]2008-05-29May 29, 2008NoNoYesRXBIONPHARMA INC7685500af04a4b1a2a72d0fdd1abace2753d5897aaffe32a49971f6404139ed1
1545A209171001AMANTADINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMANTADINE HYDROCHLORIDEHERITAGE PHARMA100MGAB["AB"]2017-06-12Jun 12, 2017NoNoNoRXHERITAGE PHARMA LABS INCd070e2b25978da8114b5e9111fa7fb71ea87e3ae0ef63b5d541b2920151ec0e7
1546A207570001AMANTADINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMANTADINE HYDROCHLORIDEINVAGEN PHARMS100MG[]2016-09-30Sep 30, 2016NoNoNoDISCNINVAGEN PHARMACEUTICALS INC8684128eb00940f66b7819a96d6ddbf1bbb14ae401f44455aece389f79614300
1547A209221001AMANTADINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMANTADINE HYDROCHLORIDELANNETT CO INC100MG[]2017-06-15Jun 15, 2017NoNoNoDISCNLANNETT CO INCefe8eb057a6dff36bc60b72735e9982b8232c17cfa615e69efa7b2a0cd3d222f
1548A210129001AMANTADINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMANTADINE HYDROCHLORIDENOVELGENIX THERAPS100MGAB["AB"]2020-03-02Mar 2, 2020NoNoNoRXNOVELGENIX THERAPEUTICS PVT LTD37499db6b06e5a5a5d1c6dff90ba2a6f6363806fc6a56c1c2bb8fc08a4fdf61e
1549A212044001AMANTADINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMANTADINE HYDROCHLORIDERUBICON100MGAB["AB"]2020-05-21May 21, 2020NoNoNoRXRUBICON RESEARCH PRIVATE LTD1fee3744b29a67e501f154c7891d0d966cec8e7ecc8020bcfc83214a167527d6
1550A071293001AMANTADINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMANTADINE HYDROCHLORIDESANDOZ100MGAB["AB"]1987-02-18Feb 18, 1987NoNoNoRXSANDOZ INCae2bbf5c605655591e3e89fb7d5fee80aae0512c1c5dce82e52b5c334cef29ad
1551A209047001AMANTADINE HYDROCHLORIDECAPSULE;ORALCAPSULEORALAMANTADINE HYDROCHLORIDESTRIDES PHARMA100MGAB["AB"]2017-06-07Jun 7, 2017NoNoNoRXSTRIDES PHARMA GLOBAL PTE LTD6f89a0ae16f1c1f10ef3fa9f51a167959d0699248d98f6fe3d62c5a708ce2d83