ANDA 202573

HIKMA

FDA Drug Application

Application #202573

Documents

• Letter: 2015-01-16
• Label: 2015-02-17

Application Sponsors

ANDA 202573

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

100MG

0

RITONAVIR

RITONAVIR

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-01-15
LABELING; Labeling	SUPPL	2	AP	2021-12-22	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-12-22	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-12-22	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-12-22	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-12-22	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-12-22	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	9	Null	15

TE Codes

001

Prescription

AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202573
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RITONAVIR","activeIngredients":"RITONAVIR","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/15\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202573Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/15\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202573Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202573Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2015-01-15
        )

)