ANDA 076723

NOSTRUM LABS INC

FDA Drug Application

Application #076723

Documents

• Other Important Information from FDA: 2005-10-27

Application Sponsors

ANDA 076723

NOSTRUM LABS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

8MG

0

HYDROMORPHONE HYDROCHLORIDE

HYDROMORPHONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2005-10-18
LABELING; Labeling	SUPPL	6	AP	2020-04-15	STANDARD
REMS; REMS	SUPPL	8	AP	2018-09-18
LABELING; Labeling	SUPPL	9	AP	2020-04-15	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-04-15	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-04-15	STANDARD

Submissions Property Types

SUPPL	6	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	7

TE Codes

001

Prescription

AB

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76723
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROMORPHONE HYDROCHLORIDE","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"8MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)