ANDA 212333

UPSHER SMITH LABS

FDA Drug Application

Application #212333

Documents

• Letter: 2021-05-06

Application Sponsors

ANDA 212333

UPSHER SMITH LABS

Marketing Status

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

Application Products

001	CAPSULE;ORAL	10MG	0	ISOTRETINOIN	ISOTRETINOIN
002	CAPSULE;ORAL	20MG	0	ISOTRETINOIN	ISOTRETINOIN
003	CAPSULE;ORAL	30MG	0	ISOTRETINOIN	ISOTRETINOIN

FDA Submissions

UNKNOWN;	ORIG	1	TA	2021-04-12	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-08-24	STANDARD
REMS; REMS	SUPPL	6	AP	2022-10-06

Submissions Property Types

ORIG	1	Null	31
SUPPL	3	Null	15
SUPPL	6	Null	7

TE Codes

001	Prescription	AB2
002	Prescription	AB2
003	Prescription	AB2

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212333
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOTRETINOIN","activeIngredients":"ISOTRETINOIN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/12\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-12
        )

)