NDA 019090

TELIGENT

FDA Drug Application

Application #019090

Documents

• Letter: 2009-02-19
• Letter: 2004-07-01
• Letter: 2002-01-07
• Letter: 2006-07-21
• Letter: 2009-11-12
• Review: 2003-04-29
• Label: 2009-03-27
• Label: 2009-10-06

Application Sponsors

NDA 019090

TELIGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 25MG BASE/ML

1

ZANTAC

RANITIDINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1984-10-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-02-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-03-03	STANDARD
LABELING; Labeling	SUPPL	9	AP	1987-04-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1987-11-24	STANDARD
LABELING; Labeling	SUPPL	12	AP	1988-05-19
LABELING; Labeling	SUPPL	13	AP	1989-03-17
LABELING; Labeling	SUPPL	14	AP	1988-05-20
LABELING; Labeling	SUPPL	15	AP	1988-05-20
LABELING; Labeling	SUPPL	16	AP	1989-03-17
EFFICACY; Efficacy	SUPPL	17	AP	1990-08-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1990-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1989-08-08	STANDARD
LABELING; Labeling	SUPPL	20	AP	1989-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1990-06-25	STANDARD
LABELING; Labeling	SUPPL	24	AP	1991-11-25
LABELING; Labeling	SUPPL	25	AP	1990-07-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1990-12-12	STANDARD
LABELING; Labeling	SUPPL	27	AP	1990-11-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1992-05-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1990-12-20	STANDARD
LABELING; Labeling	SUPPL	30	AP	1991-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1992-07-22	STANDARD
LABELING; Labeling	SUPPL	32	AP	1993-04-05
LABELING; Labeling	SUPPL	35	AP	1994-11-03	STANDARD
LABELING; Labeling	SUPPL	37	AP	1999-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1998-01-14	STANDARD
LABELING; Labeling	SUPPL	39	AP	1999-10-22	STANDARD
LABELING; Labeling	SUPPL	40	AP	1999-10-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2001-11-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1999-04-02	STANDARD
LABELING; Labeling	SUPPL	43	AP	1999-10-29	STANDARD
LABELING; Labeling	SUPPL	44	AP	2001-05-09	STANDARD
LABELING; Labeling	SUPPL	45	AP	2002-01-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	2002-01-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2002-03-14	STANDARD
LABELING; Labeling	SUPPL	50	AP	2006-07-12	STANDARD
LABELING; Labeling	SUPPL	51	AP	2009-02-17	STANDARD
LABELING; Labeling	SUPPL	53	AP	2009-09-04	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	38	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	46	Null	0
SUPPL	47	Null	0
SUPPL	53	Null	7

TE Codes

001

Prescription

AP

CDER Filings

TELIGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19090
            [companyName] => TELIGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZANTAC","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 25MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/04\/2009","submission":"SUPPL-53","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019090s053,019593s042lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2009","submission":"SUPPL-51","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019090s051,019593s039lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZANTAC","submission":"RANITIDINE HYDROCHLORIDE","actionType":"EQ 25MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2009-09-04
        )

)