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18,993 catalysts · 18,987 approval · 5,000 device 510k · 4,779 phase readout · 4,728 grant · 2,387 8k filing · 2,000 device pma

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type: filing×type: approval×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,779
  • grant4,728
  • 8k filing2,387
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • earnings294
  • therapy area
    • Ophthalmology5

    Week of Nov 10, 1997

    4
    ›Nov 13, 1997approval10480d agoZOLADEX (GOSERELIN ACETATE) — FDA approvalgoserelin LA

    Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION

    full page →goserelin LA →fda approvals ↗
    ›Nov 14, 1997approval10479d agoROGAINE EXTRA STRENGTH (FOR MEN) (MINOXIDIL) — FDA approvalVeradermics, Inc

    Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: TOPICAL

    full page →fda approvals ↗
    ›Nov 14, 1997approval10479d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

    Sponsor: HIKMA. Form: SYRUP. Route: ORAL

    full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗
    ›Nov 14, 1997approval10479d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

    Sponsor: HIKMA. Form: SYRUP. Route: ORAL

    full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

    Week of Nov 24, 1997

    3
    ›Nov 26, 1997approval10467d agoSINEMET (CARBIDOPA) — FDA approvalcarbidopa

    Sponsor: ORGANON. Form: TABLET. Route: ORAL

    full page →carbidopa →fda approvals ↗
    ›Nov 26, 1997approval

    Week of Dec 1, 1997

    6
    ›Dec 4, 1997approval10459d agoSINEMET (CARBIDOPA) — FDA approvalcarbidopa

    Sponsor: ORGANON. Form: TABLET. Route: ORAL

    full page →carbidopa →fda approvals ↗
    ›Dec 4, 1997approval

    Week of Dec 8, 1997

    4
    ›Dec 10, 1997approval10453d agoLACTULOSE — FDA approvalCUMBERLAND PHARMACEUTICALS INC

    Sponsor: CUMBERLAND PHARMS. Form: FOR SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Dec 12, 1997approval

    Week of Dec 15, 1997

    17
    ›Dec 15, 1997approval10448d agoVALPROIC ACID — FDA approvalCereno Scientific AB

    Sponsor: CHARTWELL RX. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 15, 1997approval

    Week of Dec 22, 1997

    2
    ›Dec 24, 1997approval10439d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

    Sponsor: ABBVIE. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →divalproex sodium DR →fda approvals ↗
    ›Dec 24, 1997approval

    Week of Jan 5, 1998

    2
    ›Jan 8, 1998approval10424d agoDYNA-HEX 2 (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

    Sponsor: XTTRIUM. Form: SOLUTION. Route: TOPICAL

    full page →fda approvals ↗
    ›Jan 8, 1998approval

    Week of Jan 12, 1998

    2
    ›Jan 14, 1998approval10418d agoMEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (MEPERIDINE HYDROCHLORIDE) — FDA approvalHikma Pharmaceuticals Plc

    Sponsor: INTL MEDICATION. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Jan 15, 1998approval

    Week of Jan 19, 1998

    1
    ›Jan 20, 1998approval10412d agoALFENTA (ALFENTANIL HYDROCHLORIDE) — FDA approvalalfentanil hydrochloride

    Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

    full page →alfentanil hydrochloride →fda approvals ↗

    Week of Jan 26, 1998

    5
    ›Jan 27, 1998approval10405d agoFOSAMAX (ALENDRONATE SODIUM) — FDA approvalALENDRONATE SODIUM

    Sponsor: ORGANON. Form: TABLET. Route: ORAL

    full page →ALENDRONATE SODIUM →fda approvals ↗
    ›Jan 27, 1998approval

    Week of Feb 2, 1998

    2
    ›Feb 3, 1998approval10398d agoREGLAN (METOCLOPRAMIDE HYDROCHLORIDE) — FDA approvalANI PHARMACEUTICALS INC

    Sponsor: ANI PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Feb 5, 1998approval

    Week of Feb 9, 1998

    2
    ›Feb 9, 1998approval10392d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

    Sponsor: PHARMOBEDIENT. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Feb 10, 1998approval
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    10467d ago
    CLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 26, 1997approval10467d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

    Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
    10459d ago
    ZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

    Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 5, 1997approval10458d agoMETHYLPREDNISOLONE — FDA approvalMEDROL

    Sponsor: SANDOZ. Form: TABLET. Route: ORAL

    full page →MEDROL →fda approvals ↗
    ›Dec 5, 1997approval10458d agoMETRONIDAZOLE — FDA approvalMETRONIDAZOLE

    Sponsor: INNOGENIX. Form: TABLET. Route: ORAL

    full page →METRONIDAZOLE →fda approvals ↗
    ›Dec 5, 1997approval10458d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

    Sponsor: RHODES PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 7, 1997approval10456d agoCEREZYME (IMIGLUCERASE) — FDA approvalimiglucerase

    Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION

    full page →imiglucerase →fda approvals ↗
    10451d ago
    CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →CLEOCIN →fda approvals ↗
    ›Dec 12, 1997approval10451d agoCLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) — FDA approvalclindamycin hydrochloride

    Sponsor: PFIZER. Form: CAPSULE. Route: ORAL

    full page →clindamycin hydrochloride →fda approvals ↗
    ›Dec 12, 1997approval10451d agoCLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →CLEOCIN →fda approvals ↗
    10448d ago
    VALPROIC ACID — FDA approvalCereno Scientific AB

    Sponsor: CHARTWELL RX. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 15, 1997approval10448d agoVALPROIC ACID — FDA approvalCereno Scientific AB

    Sponsor: CHARTWELL RX. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 15, 1997approval10448d agoVALPROIC ACID — FDA approvalCereno Scientific AB

    Sponsor: CHARTWELL RX. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 15, 1997approval10448d agoVALPROIC ACID — FDA approvalCereno Scientific AB

    Sponsor: CHARTWELL RX. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 16, 1997approval10447d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalANI PHARMACEUTICALS INC

    Sponsor: ANI PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 16, 1997approval10447d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

    Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
    ›Dec 16, 1997approval10447d agoIMITREX (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
    ›Dec 16, 1997approval10447d agoWELLBUTRIN SR (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: GLAXOSMITHKLINE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Dec 16, 1997approval10447d agoWELLBUTRIN SR (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: GLAXOSMITHKLINE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Dec 17, 1997approval10446d agoOXYCET (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 17, 1997approval10446d agoOXYCET (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 17, 1997approval10446d agoOXYCET (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 17, 1997approval10446d agoOXYCET (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 17, 1997approval10446d agoOXYCET (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 17, 1997approval10446d agoOXYCET (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 19, 1997approval10444d agoPROSCAR (FINASTERIDE) — FDA approvalPROSCAR

    Sponsor: ORGANON. Form: TABLET. Route: ORAL

    full page →PROSCAR →fda approvals ↗
    10439d ago
    NIPENT (PENTOSTATIN) — FDA approvalpentostatin

    Sponsor: HOSPIRA INC. Form: INJECTABLE. Route: INJECTION

    full page →pentostatin →fda approvals ↗
    10424d ago
    LUPRON (LEUPROLIDE ACETATE) — FDA approvalInvaGen Pharmaceuticals Inc

    Sponsor: ABBVIE ENDOCRINE INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    10417d ago
    IOPIDINE (APRACLONIDINE HYDROCHLORIDE) — FDA approvalHARROW, INC.

    Sponsor: HARROW EYE. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →fda approvals ↗
    10405d ago
    CLEOCIN T (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

    Sponsor: PFIZER. Form: GEL. Route: TOPICAL

    full page →CLEOCIN →fda approvals ↗
    ›Jan 30, 1998approval10402d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

    Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

    full page →Restasis →fda approvals ↗
    ›Jan 30, 1998approval10402d agoREGLAN (METOCLOPRAMIDE HYDROCHLORIDE) — FDA approvalmetoclopramide hydrochloride

    Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

    full page →metoclopramide hydrochloride →fda approvals ↗
    ›Jan 30, 1998approval10402d agoCEREZYME (IMIGLUCERASE) — FDA approvalimiglucerase

    Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION

    full page →imiglucerase →fda approvals ↗
    10396d ago
    TRIAMTERENE AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalChartwell Pharmaceuticals LLC

    Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    10391d ago
    PHENERGAN W/ CODEINE (CODEINE PHOSPHATE) — FDA approvalANI PHARMACEUTICALS INC

    Sponsor: ANI PHARMS. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    $MANE
    $OGN13.56+0.30%
    $OGN13.56+0.30%
    $CPIX6.9850-1.83%
    $ABBV256.92+1.43%
    $OGN13.56+0.30%
    $ANIP78.53+1.19%
    $TEVA31.18+3.42%
    $PFE25.01+0.77%
    $PFE25.01+0.77%
    $PFE25.01+0.77%
    $ANIP78.53+1.19%
    $OGN13.56+0.30%
    $HROW41.88-2.22%
    $PFE25.01+0.77%
    $NVS156.14+2.00%
    $ANIP78.53+1.19%