ALEMBIC PHARMS LTD FDA Approval ANDA 206098

ANDA 206098

ALEMBIC PHARMS LTD

FDA Drug Application

Application #206098

Documents

Letter2017-09-07

Application Sponsors

ANDA 206098ALEMBIC PHARMS LTD

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
Prescription003

Application Products

001TABLET;SUBLINGUAL5MG0ASENAPINEASENAPINE
002TABLET;SUBLINGUAL10MG0ASENAPINEASENAPINE
003TABLET;SUBLINGUALEQ 2.5MG BASE0ASENAPINE MALEATEASENAPINE MALEATE

FDA Submissions

UNKNOWN; ORIG1TA2019-12-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2021-07-19UNKNOWN

Submissions Property Types

ORIG1Null31
SUPPL2Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206098
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ASENAPINE","activeIngredients":"ASENAPINE","strength":"5MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ASENAPINE","activeIngredients":"ASENAPINE","strength":"10MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/16\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206098Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-16
        )

)

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