NDA 211913

SUN PHARM

FDA Drug Application

Application #211913

Documents

• Label: 2019-11-08
• Letter: 2019-11-08
• Review: 2020-03-16
• Letter: 2020-12-10
• Letter: 2021-10-13
• Letter: 2022-04-08
• Label: 2022-04-14
• Letter: 2022-10-07

Application Sponsors

NDA 211913

SUN PHARM

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	CAPSULE;ORAL	8MG	1	ABSORICA LD	ISOTRETINOIN
002	CAPSULE;ORAL	16MG	1	ABSORICA LD	ISOTRETINOIN
003	CAPSULE;ORAL	20MG	1	ABSORICA LD	ISOTRETINOIN
004	CAPSULE;ORAL	24MG	1	ABSORICA LD	ISOTRETINOIN
005	CAPSULE;ORAL	28MG	1	ABSORICA LD	ISOTRETINOIN
006	CAPSULE;ORAL	32MG	1	ABSORICA LD	ISOTRETINOIN

FDA Submissions

TYPE 4/5;	ORIG	1	AP	2019-11-05	STANDARD
REMS; REMS	SUPPL	3	AP	2020-12-09	N/A
REMS; REMS	SUPPL	4	AP	2021-10-08	N/A
LABELING; Labeling	SUPPL	5	AP	2022-04-07	STANDARD
REMS; REMS	SUPPL	9	AP	2022-10-06	N/A

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	6
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	9	Null	7

CDER Filings

SUN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211913
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABSORICA LD","activeIngredients":"ISOTRETINOIN","strength":"8MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ABSORICA LD","activeIngredients":"ISOTRETINOIN","strength":"16MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ABSORICA LD","activeIngredients":"ISOTRETINOIN","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ABSORICA LD","activeIngredients":"ISOTRETINOIN","strength":"24MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ABSORICA LD","activeIngredients":"ISOTRETINOIN","strength":"28MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ABSORICA LD","activeIngredients":"ISOTRETINOIN","strength":"32MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/05\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211913lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/05\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211913lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211913Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211913Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/09\/2020","submission":"SUPPL-3","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211913Orig1s003ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-12-09
        )

)