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calendar

18,993 catalysts · 18,987 approval · 5,347 phase readout · 5,000 device 510k · 4,728 grant · 2,603 8k filing · 2,000 device pma

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  • approval18,987
  • phase readout5,347
  • device 510k5,000
  • grant4,728
  • 8k filing2,603
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
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    • Ophthalmology5

    Week of Oct 24, 2011

    12
    ›Oct 24, 2011approval5397d agoOLANZAPINE — FDA approvalolanzapine ODT

    Sponsor: DR REDDYS LABS LTD. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →olanzapine ODT →fda approvals ↗
    ›Oct 25, 2011approval5396d agoOLANZAPINE — FDA approvalolanzapine ODT

    Sponsor: TORRENT. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →olanzapine ODT →fda approvals ↗
    ›Oct 25, 2011approval5396d agoDEXTROAMPHETAMINE SULFATE — FDA approvalDEXTROAMPHETAMINE SULFATE

    Sponsor: AZURITY. Form: TABLET. Route: ORAL

    full page →DEXTROAMPHETAMINE SULFATE →fda approvals ↗
    ›Oct 26, 2011approval5395d agoCABERGOLINE — FDA approvalCABERGOLINE

    Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

    full page →CABERGOLINE →fda approvals ↗
    ›Oct 26, 2011approval5395d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    ›Oct 28, 2011approval5393d agoCARTIA XT (DILTIAZEM HYDROCHLORIDE) — FDA approvalBausch Health US LLC

    Sponsor: ACTAVIS LABS FL INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 30, 2011approval5391d agoTEGRETOL-XR (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

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

    full page →carbamazepine ER →fda approvals ↗
    ›Oct 30, 2011approval5391d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Oct 30, 2011approval5391d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

    Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Oct 30, 2011approval5391d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

    Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

    full page →OXCARBAZEPINE →fda approvals ↗
    ›Oct 30, 2011approval5391d agoSUPPRELIN LA (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

    Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Oct 30, 2011approval5391d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →OXCARBAZEPINE →fda approvals ↗

    Week of Oct 31, 2011

    4
    ›Oct 31, 2011approval5390d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

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

    full page →fda approvals ↗
    ›Oct 31, 2011approval

    Week of Nov 7, 2011

    4
    ›Nov 8, 2011approval5382d agoRISPERIDONE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: AMNEAL PHARMS. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Nov 10, 2011approval

    Week of Nov 14, 2011

    7
    ›Nov 14, 2011approval5376d agoMORPHINE SULFATE — FDA approvalKapanol

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

    full page →Kapanol →fda approvals ↗
    ›Nov 14, 2011approval

    Week of Nov 21, 2011

    1
    ›Nov 22, 2011approval5368d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

    Week of Nov 28, 2011

    13
    ›Nov 28, 2011approval5362d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

    Sponsor: STRIDES PHARMA. Form: TABLET. Route: ORAL

    full page →tramadol hydrochloride ER →fda approvals ↗
    ›Nov 28, 2011approval

    Week of Dec 5, 2011

    1
    ›Dec 7, 2011approval5353d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

    Sponsor: SUN PHARM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗

    Week of Dec 12, 2011

    3
    ›Dec 13, 2011approval5347d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Dec 13, 2011approval

    Week of Dec 19, 2011

    3
    ›Dec 20, 2011approval5340d agoAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN) — FDA approvalamoxicillin

    Sponsor: AUROBINDO PHARMA LTD. Form: FOR SUSPENSION. Route: ORAL

    full page →amoxicillin →fda approvals ↗
    ›Dec 22, 2011approval

    Week of Dec 26, 2011

    2
    ›Dec 26, 2011approval5334d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

    Sponsor: ABBVIE INC. Form: VIAL

    full page →adalimumab →fda approvals ↗
    ›Dec 26, 2011approval
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    5390d ago
    DEMEROL (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

    Sponsor: QUAGEN. Form: TABLET. Route: ORAL

    full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗
    ›Nov 1, 2011approval5389d agoPROMETRIUM (PROGESTERONE) — FDA approvalIBSA Institut Biochimique SA

    Sponsor: ACERTIS PHARMS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Nov 4, 2011approval5386d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

    Sponsor: APOTEX. Form: TABLET. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    5380d ago
    MORPHINE SULFATE — FDA approvalKapanol

    Sponsor: STRIDES PHARMA INTL. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →Kapanol →fda approvals ↗
    ›Nov 10, 2011approval5380d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

    Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Nov 10, 2011approval5380d agoFORFIVO XL (BUPROPION HYDROCHLORIDE) — FDA approvalTWi Pharmaceuticals Inc

    Sponsor: TWI PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    5376d ago
    ANASTROZOLE — FDA approvalANASTROZOLE

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →ANASTROZOLE →fda approvals ↗
    ›Nov 14, 2011approval5376d agoLANOXIN PEDIATRIC (DIGOXIN) — FDA approvalDIGOXIN

    Sponsor: AZURITY. Form: INJECTABLE. Route: INJECTION

    full page →DIGOXIN →fda approvals ↗
    ›Nov 16, 2011approval5374d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

    Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 16, 2011approval5374d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

    Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Nov 16, 2011approval5374d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

    Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Nov 16, 2011approval5374d agoEOVIST (GADOXETATE DISODIUM) — FDA approval

    Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    5362d ago
    CIPROFLOXACIN HYDROCHLORIDE — FDA approvalBayer HealthCare Pharmaceuticals Inc

    Sponsor: UNIQUE. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 28, 2011approval5362d agoANASTROZOLE — FDA approvalANASTROZOLE

    Sponsor: SANDOZ. Form: TABLET. Route: ORAL

    full page →ANASTROZOLE →fda approvals ↗
    ›Nov 29, 2011approval5361d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗
    ›Nov 29, 2011approval5361d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

    Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Nov 29, 2011approval5361d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Nov 29, 2011approval5361d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

    Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Nov 29, 2011approval5361d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Nov 30, 2011approval5360d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

    Sponsor: IMPAX LABS INC. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Nov 30, 2011approval5360d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

    Sponsor: IMPAX LABS INC. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Nov 30, 2011approval5360d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

    Sponsor: HIKMA INTL PHARMS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Nov 30, 2011approval5360d agoDOXYCYCLINE — FDA approvalPrasco LLC

    Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 1, 2011approval5359d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalHYDROMORPHONE HYDROCHLORIDE

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

    full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗
    5347d ago
    HUMIRA (ADALIMUMAB) — FDA approvaladalimumab

    Sponsor: ABBVIE INC. Form: VIAL

    full page →adalimumab →fda approvals ↗
    ›Dec 15, 2011approval5345d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

    full page →DOXYCYCLINE HYCLATE →fda approvals ↗
    5338d ago
    ENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗
    ›Dec 23, 2011approval5337d agoHEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM) — FDA approvalHEPARIN SODIUM

    Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

    full page →HEPARIN SODIUM →fda approvals ↗
    5334d ago
    SIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

    Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    $RDY11.85+0.17%
    $NVS156.15-1.45%
    $ABBV250.94-2.51%
    $AMRX18.32-0.97%
    $AMRX18.32-0.97%
    $NVS156.15-1.45%
    $NVS156.15-1.45%
    $NVS156.15-1.45%
    $NVS156.15-1.45%
    $AMGN385.16-0.64%
    $PYPD4.2900-1.83%
    $ABBV250.94-2.51%
    $PYPD4.2900-1.83%
    $PYPD4.2900-1.83%
    $AMGN385.16-0.64%