ANDA 207848

APOLLO

FDA Drug Application

Application #207848

Application Sponsors

ANDA 207848

APOLLO

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	0	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
002	INJECTABLE;INJECTION	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	0	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-01-13	STANDARD
UNKNOWN;	ORIG	2	AP	2018-05-11	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-03-04	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-03-04	STANDARD

Submissions Property Types

ORIG	1	Null	1
ORIG	2	Null	1
SUPPL	7	Null	7
SUPPL	8	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

APOLLO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207848
            [companyName] => APOLLO
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIPERACILLIN AND TAZOBACTAM","activeIngredients":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","strength":"EQ 12GM BASE\/VIAL;EQ 1.5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIPERACILLIN AND TAZOBACTAM","activeIngredients":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","strength":"EQ 36GM BASE\/VIAL;EQ 4.5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/11\/2018","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/13\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-11
        )

)