Wednesday, September 10, 2014 11:08:00 AM
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$ELTP NDA filings will be as follows:
$ELTP 1st ADT is ELI-200 Morphine/Naltrexone.
$ELTP 2nd ADT is ELI-202 Hydrocodone/Naltrexone
$ELTP 3rd ADT is ELI-201 Oxycodone/Naltrexone.
The above info was posted by Lasers on Aug 22, 2014
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Firstly ELI-200 (Morphine) and then secondly ELI-202 (Hydrocodone). ELI-201 (Oxycodone 12 Hr ER)will be third and followed by ELI-216 (Oxycodone 24 Hr ER) 4th.
ELI-200 and ELI-202 will dominate opioid sector so that $ELTP can take their time with moving forward with ELI-201 and ELI-216
The above info was posted by Lasers on Sept 8, 2014
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NEXT FOUR MONTHS
Isradipine 2.5 mg and 5.0 mg capsules Approval
Isradipine 2.5 mg and 5.0 mg capsules Launch
Dantrolene Sodium 25 mg, 50 mg and 100 mg capsules Approval
Dantrolene Sodium 25 mg, 50 mg and 100 mg capsules Launch
Loxapine 5mg, 10mg, 25 mg, 50 mg capsules Approval
Loxapine 5mg, 10mg, 25 mg, 50 mg capsules Launch
Hydroxyzine HCI 10 mg, 25 mg, 50 mg tablets Approval
Hydroxyzine HCI 10 mg, 25 mg, 50 mg tablets Launch
ELI-201 Pivotal BE Results
ELI-202 Pivotal BE Results
ELI-200 In Vitro Lab Abuse Study Results
ELI-200 In Vivo Human Abuse Liability Results
ELI-202 In Vitro Lab Abuse Study Results
ELI-202 In Vivo Human Abuse Liability Results
ELI-203 Pivotal BE Study Initiation
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December ELI-200 NDA ART FDA Filing
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