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calendar

28,950 catalysts · 9,622 approval · 5,000 device 510k · 4,728 grant · 2,809 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2017-08-10×clear all

type

approval9,622
device 510k5,000
grant4,728
8k filing2,809
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings374

phase 2 completion172

therapy area

Oncology148
Infectious Disease46
Cardiology37
Immunology35
Dermatology31
Pulmonology22
Women's Health19
Ophthalmology16
Pain15

Week of Sep 30, 2019

›Oct 4, 2019approval2498d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ELITE LABS INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Oct 4, 2019approval2498d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

›Oct 4, 2019approval2498d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

›Oct 4, 2019approval2498d agoTRIPTODUR KIT (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: AZURITY. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗

›Oct 6, 2019approval2496d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

›Oct 6, 2019approval2496d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Week of Oct 7, 2019

›Oct 7, 2019approval2495d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›Oct 7, 2019approval

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page 30 of 579

2495d ago

OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ALVOGEN. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Oct 7, 2019approval2495d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Oct 7, 2019approval2495d agoALFENTA (ALFENTANIL HYDROCHLORIDE) — FDA approvalalfentanil hydrochloride

Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

full page →alfentanil hydrochloride →fda approvals ↗

›Oct 7, 2019approval2495d agoPERCOCET (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: OZANTRI. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Oct 7, 2019approval2495d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: GENUS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

›Oct 7, 2019approval2495d agoNUBAIN (NALBUPHINE HYDROCHLORIDE) — FDA approvalTrevi Therapeutics, Inc.

Sponsor: PH HEALTH. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →fda approvals ↗

›Oct 7, 2019approval2495d agoACTIQ (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TROCHE/LOZENGE. Route: TRANSMUCOSAL

full page →fda approvals ↗

›Oct 7, 2019approval2495d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

Sponsor: HIKMA. Form: SPRAY, METERED. Route: NASAL

full page →BUTORPHANOL TARTRATE →fda approvals ↗

›Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗

›Oct 7, 2019approval2495d agoDEMEROL (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: QUAGEN. Form: TABLET. Route: ORAL

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

›Oct 7, 2019approval2495d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →Kapanol →fda approvals ↗

›Oct 7, 2019approval2495d agoMEPERGAN (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

›Oct 7, 2019approval2495d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›Oct 7, 2019approval2495d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →Kapanol →fda approvals ↗

›Oct 7, 2019approval2495d agoMORPHINE SULFATE — FDA approvalKapanol

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

full page →Kapanol →fda approvals ↗

›Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗

›Oct 7, 2019approval2495d agoBELBUCA (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: BDSI. Form: FILM. Route: BUCCAL

full page →fda approvals ↗

›Oct 7, 2019approval2495d agoFIORICET W/ CODEINE (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: ACTAVIS LABS UT INC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Oct 7, 2019approval2495d agoDEMEROL (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

›Oct 7, 2019approval2495d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

Sponsor: BARR LABS INC. Form: TABLET. Route: ORAL

full page →Midol →fda approvals ↗

›Oct 7, 2019approval2495d agoOXYCONTIN (OXYCODONE HYDROCHLORIDE) — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: PURDUE PHARMA LP. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

›Oct 7, 2019approval2495d agoPROBUPHINE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: REACX PHARMS. Form: IMPLANT. Route: IMPLANTATION

full page →fda approvals ↗

›Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Oct 7, 2019approval2495d agoDILAUDID-HP (HYDROMORPHONE HYDROCHLORIDE) — FDA approvalHYDROMORPHONE HYDROCHLORIDE

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗

›Oct 7, 2019approval2495d agoPERCODAN (ASPIRIN) — FDA approvalEndo Pharmaceuticals Inc

Sponsor: ENDO OPERATIONS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Oct 7, 2019approval2495d agoDURAMORPH PF (MORPHINE SULFATE) — FDA approvalKapanol

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Kapanol →fda approvals ↗

›Oct 7, 2019approval2495d agoROXYBOND (OXYCODONE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›Oct 7, 2019approval2495d agoCODEINE SULFATE — FDA approvalcodeine

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →codeine →fda approvals ↗

›Oct 7, 2019approval2495d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Oct 7, 2019approval2495d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Oct 7, 2019approval2495d agoNUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

Sponsor: COLLEGIUM PHARM INC. Form: TABLET. Route: ORAL

full page →tapentadol hydrochloride ER →fda approvals ↗

›Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗

›Oct 7, 2019approval2495d agoDILAUDID (HYDROMORPHONE HYDROCHLORIDE) — FDA approvalSpecGx LLC

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

full page →fda approvals ↗

›Oct 7, 2019approval2495d agoFENTORA (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TABLET. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

›Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Oct 7, 2019approval2495d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ABHAI LLC. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Oct 7, 2019approval2495d agoDILAUDID (HYDROMORPHONE HYDROCHLORIDE) — FDA approvalSpecGx LLC

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

full page →fda approvals ↗

›Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: PAI HOLDINGS. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Oct 7, 2019approval2495d agoSUBLIMAZE PRESERVATIVE FREE (FENTANYL CITRATE) — FDA approvalEffentora

Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

full page →Effentora →fda approvals ↗

›Oct 7, 2019approval2495d agoULTIVA (REMIFENTANIL HYDROCHLORIDE) — FDA approvalremifentanil hydrochloride

Sponsor: MYLAN INSTITUTIONAL. Form: INJECTABLE. Route: INJECTION

full page →remifentanil hydrochloride →fda approvals ↗

$NVS154.44+0.76%

$IGC0.2670+0.41%

$AMRX18.46-0.11%

$NVS154.44+0.76%

$TRVI

$IGC0.2670+0.41%

$BLNC

$IGC0.2670+0.41%

$AMRX18.46-0.11%

$COLL35.74+0.03%