ANDA 091620

SANDOZ INC

FDA Drug Application

Application #091620

Application Sponsors

ANDA 091620

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

50MG/VIAL

0

TIGECYCLINE

TIGECYCLINE

FDA Submissions

	ORIG	1	AP	2015-05-27
LABELING; Labeling	SUPPL	2	AP	2017-09-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2017-09-29
LABELING; Labeling	SUPPL	6	AP	2020-04-09	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-04-09	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-01-25	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	10	Null	15

TE Codes

001

Prescription

AP

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91620
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIGECYCLINE","activeIngredients":"TIGECYCLINE","strength":"50MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TIGECYCLINE","submission":"TIGECYCLINE","actionType":"50MG\/VIAL","submissionClassification":"POWDER;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)