ANDA 090034

LUPIN PHARMS

FDA Drug Application

Application #090034

Application Sponsors

ANDA 090034

LUPIN PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	150MG	0	RIFAMPIN	RIFAMPIN
002	CAPSULE;ORAL	300MG	0	RIFAMPIN	RIFAMPIN

FDA Submissions

	ORIG	1	AP	2013-08-21
LABELING; Labeling	SUPPL	8	AP	2020-03-31	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-03-31	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-03-31	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-03-31	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-03-31	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-08-17	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-09-14	STANDARD
LABELING; Labeling	SUPPL	17	AP	2022-08-30	STANDARD
LABELING; Labeling	SUPPL	18	AP	2022-08-30	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	7
SUPPL	15	Null	15
SUPPL	17	Null	15
SUPPL	18	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LUPIN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90034
            [companyName] => LUPIN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIFAMPIN","activeIngredients":"RIFAMPIN","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIFAMPIN","activeIngredients":"RIFAMPIN","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RIFAMPIN","submission":"RIFAMPIN","actionType":"150MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RIFAMPIN","submission":"RIFAMPIN","actionType":"300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)