NDA 215133

ALMATICA

FDA Drug Application

Application #215133

Documents

• Label: 2021-10-05
• Letter: 2021-10-05
• Letter: 2021-10-05
• Review: 2022-06-22
• Review: 2022-06-22

Application Sponsors

NDA 215133

ALMATICA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE; ORAL	150MG	0	ZERCAPLI	SERTRALINE HYDROCHORIDE
002	CAPSULE; ORAL	200MG	0	ZERCAPLI	SERTRALINE HYDROCHORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2021-10-04	STANDARD
TYPE 3; Type 3 - New Dosage Form	ORIG	2	AP	2021-10-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
ORIG	2	Null	40

TE Codes

001	Prescription	TBD
002	Prescription	TBD

CDER Filings

ALMATICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215133
            [companyName] => ALMATICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZERCAPLI","activeIngredients":"SERTRALINE HYDROCHORIDE","strength":"150MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ZERCAPLI","activeIngredients":"SERTRALINE HYDROCHORIDE","strength":"200MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/04\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215133s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/04\/2021","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/04\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215133s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-10-04
        )

)