ANDA 206098

ALEMBIC PHARMS LTD

FDA Drug Application

Application #206098

Documents

• Letter: 2017-09-07

Application Sponsors

ANDA 206098

ALEMBIC PHARMS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• Prescription: 003

Application Products

001	TABLET;SUBLINGUAL	5MG	0	ASENAPINE	ASENAPINE
002	TABLET;SUBLINGUAL	10MG	0	ASENAPINE	ASENAPINE
003	TABLET;SUBLINGUAL	EQ 2.5MG BASE	0	ASENAPINE MALEATE	ASENAPINE MALEATE

FDA Submissions

UNKNOWN;	ORIG	1	TA	2019-12-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2021-07-19	UNKNOWN

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

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
        )

)