NDA 006823

CASPER PHARMA LLC

FDA Drug Application

Application #006823

Application Sponsors

NDA 006823

CASPER PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 50,000 UNITS BASE/ML

1

AQUASOL A

VITAMIN A PALMITATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1949-05-18	UNKNOWN
LABELING; Labeling	SUPPL	4	AP	1980-01-30
LABELING; Labeling	SUPPL	5	AP	1982-04-20
LABELING; Labeling	SUPPL	6	AP	1983-10-03
LABELING; Labeling	SUPPL	8	AP	1984-09-19
LABELING; Labeling	SUPPL	9	AP	1984-09-19
LABELING; Labeling	SUPPL	11	AP	1989-07-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1990-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1993-02-02
LABELING; Labeling	SUPPL	14	AP	2000-06-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-04-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1999-12-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2014-11-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2015-09-18

Submissions Property Types

SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0

CDER Filings

CASPER PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 6823
            [companyName] => CASPER PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AQUASOL A","activeIngredients":"VITAMIN A PALMITATE","strength":"EQ 50,000 UNITS BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AQUASOL A","submission":"VITAMIN A PALMITATE","actionType":"EQ 50,000 UNITS BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)