NDA 016750

AMPHASTAR PHARMS INC

FDA Drug Application

Application #016750

Documents

• Letter: 2002-11-08
• Letter: 2021-12-16
• Label: 2021-12-16

Application Sponsors

NDA 016750

AMPHASTAR PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.25MG/VIAL

1

CORTROSYN

COSYNTROPIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1970-04-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-04-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-10-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	1986-04-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-02-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-05-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-02-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-05-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-10-28	STANDARD
LABELING; Labeling	SUPPL	10	AP	1989-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1994-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1997-04-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1997-01-29	STANDARD
LABELING; Labeling	SUPPL	15	AP	1998-01-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1999-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2000-12-07	STANDARD
LABELING; Labeling	SUPPL	18	AP	2002-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2014-09-29	STANDARD
LABELING; Labeling	SUPPL	32	AP	2021-12-14	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	28	Null	0
SUPPL	32	Null	15

TE Codes

001

Prescription

AP

CDER Filings

AMPHASTAR PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16750
            [companyName] => AMPHASTAR PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CORTROSYN","activeIngredients":"COSYNTROPIN","strength":"0.25MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CORTROSYN","submission":"COSYNTROPIN","actionType":"0.25MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)