ANDA 080737

AM REGENT

FDA Drug Application

Application #080737

Documents

• Letter: 2021-08-02
• Label: 2021-08-04

Application Sponsors

ANDA 080737

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

1

CYANOCOBALAMIN

CYANOCOBALAMIN

FDA Submissions

	ORIG	1	AP	1972-04-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-08-16
LABELING; Labeling	SUPPL	5	AP	1988-10-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1986-01-17
LABELING; Labeling	SUPPL	9	AP	1988-10-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1992-07-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1992-07-29
LABELING; Labeling	SUPPL	12	AP	1989-11-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1996-02-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1996-09-17
LABELING; Labeling	SUPPL	15	AP	1996-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1997-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2000-09-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1999-11-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-02-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-05-14
LABELING; Labeling	SUPPL	21	AP	2001-05-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2002-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2002-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2021-05-24	UNKNOWN

Submissions Property Types

SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	40	Null	15

TE Codes

001

Prescription

AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80737
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYANOCOBALAMIN","activeIngredients":"CYANOCOBALAMIN","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/24\/2021","submission":"SUPPL-40","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/080737Orig1s040lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CYANOCOBALAMIN","submission":"CYANOCOBALAMIN","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-05-24
        )

)