NDA 019593

TELIGENT

FDA Drug Application

Application #019593

Documents

• Letter: 2002-01-07
• Letter: 2009-11-12
• Label: 1999-10-29
• Label: 2009-03-27
• Label: 2009-10-06
• Letter: 2003-04-30
• Letter: 2006-07-21
• Letter: 2009-02-19
• Review: 2003-04-30

Application Sponsors

NDA 019593

TELIGENT

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 50MG BASE/100ML	0	ZANTAC IN PLASTIC CONTAINER	RANITIDINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 1MG BASE/ML	0	ZANTAC IN PLASTIC CONTAINER	RANITIDINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1986-12-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-05-18	STANDARD
LABELING; Labeling	SUPPL	4	AP	1988-01-04
LABELING; Labeling	SUPPL	5	AP	1989-03-17
LABELING; Labeling	SUPPL	6	AP	1988-05-20
LABELING; Labeling	SUPPL	7	AP	1988-05-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1989-08-08	STANDARD
LABELING; Labeling	SUPPL	10	AP	1989-05-18
LABELING; Labeling	SUPPL	11	AP	1990-08-13
LABELING; Labeling	SUPPL	12	AP	1991-11-25
LABELING; Labeling	SUPPL	13	AP	1990-07-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1990-12-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1991-01-17	STANDARD
LABELING; Labeling	SUPPL	16	AP	1990-11-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1990-12-20	STANDARD
LABELING; Labeling	SUPPL	18	AP	1991-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1992-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1992-07-22	STANDARD
LABELING; Labeling	SUPPL	21	AP	1993-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1992-08-12	STANDARD
LABELING; Labeling	SUPPL	25	AP	1994-08-10	STANDARD
LABELING; Labeling	SUPPL	26	AP	1994-11-03	STANDARD
LABELING; Labeling	SUPPL	28	AP	1999-10-29	STANDARD
LABELING; Labeling	SUPPL	29	AP	1999-10-22	STANDARD
LABELING; Labeling	SUPPL	30	AP	1999-10-22	STANDARD
LABELING; Labeling	SUPPL	31	AP	1999-10-29	STANDARD
LABELING; Labeling	SUPPL	32	AP	2001-05-09	STANDARD
LABELING; Labeling	SUPPL	33	AP	2002-01-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2002-01-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2001-12-13	STANDARD
LABELING; Labeling	SUPPL	38	AP	2006-07-12	STANDARD
LABELING; Labeling	SUPPL	39	AP	2009-02-17	STANDARD
LABELING; Labeling	SUPPL	42	AP	2009-09-04	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	8	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	23	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	42	Null	6

CDER Filings

TELIGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19593
            [companyName] => TELIGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZANTAC IN PLASTIC CONTAINER","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 50MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZANTAC IN PLASTIC CONTAINER","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 1MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/04\/2009","submission":"SUPPL-42","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-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019090s051,019593s039lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/1999","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/019593s028lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZANTAC IN PLASTIC CONTAINER","submission":"RANITIDINE HYDROCHLORIDE","actionType":"EQ 50MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZANTAC IN PLASTIC CONTAINER","submission":"RANITIDINE HYDROCHLORIDE","actionType":"EQ 1MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2009-09-04
        )

)