GLAXOSMITHKLINE FDA Approval NDA 050461

Application #050461

Documents

Letter	2005-01-11
Label	2004-01-22
Letter	2004-01-22
Letter	2004-06-07
Label	2004-06-07

Application Sponsors

NDA 050461

GLAXOSMITHKLINE

Marketing Status

Discontinued	001
Discontinued	002
Discontinued	003
Discontinued	004
Discontinued	005

Application Products

001	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	1	ANCEF	CEFAZOLIN SODIUM
002	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	1	ANCEF	CEFAZOLIN SODIUM
003	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	1	ANCEF	CEFAZOLIN SODIUM
004	INJECTABLE;INJECTION	EQ 5GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	1	ANCEF	CEFAZOLIN SODIUM
005	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	1	ANCEF	CEFAZOLIN SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	1973-10-04	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1990-02-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1992-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1992-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1991-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1992-06-22
LABELING; Labeling	SUPPL	51	AP	1974-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1974-03-15
LABELING; Labeling	SUPPL	53	AP	1974-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1974-06-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1974-09-26
LABELING; Labeling	SUPPL	56	AP	1974-09-26
LABELING; Labeling	SUPPL	57	AP	1974-12-24
LABELING; Labeling	SUPPL	58	AP	1975-02-18
LABELING; Labeling	SUPPL	59	AP	1975-02-25
LABELING; Labeling	SUPPL	60	AP	1975-04-10
LABELING; Labeling	SUPPL	61	AP	1975-04-10
LABELING; Labeling	SUPPL	62	AP	1975-04-29
LABELING; Labeling	SUPPL	63	AP	1975-05-12
LABELING; Labeling	SUPPL	64	AP	1975-07-07
LABELING; Labeling	SUPPL	65	AP	1977-06-08
LABELING; Labeling	SUPPL	66	AP	1975-09-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	67	AP	1975-09-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	68	AP	1975-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	69	AP	1975-11-20
LABELING; Labeling	SUPPL	70	AP	1976-02-26
LABELING; Labeling	SUPPL	71	AP	1976-02-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	72	AP	1976-03-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	73	AP	1976-03-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	74	AP	1976-03-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	75	AP	1976-05-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	76	AP	1976-05-10
LABELING; Labeling	SUPPL	77	AP	1976-06-08
LABELING; Labeling	SUPPL	78	AP	1976-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	79	AP	1976-07-08
LABELING; Labeling	SUPPL	80	AP	1976-08-05
LABELING; Labeling	SUPPL	81	AP	1976-08-12
LABELING; Labeling	SUPPL	82	AP	1976-10-08
LABELING; Labeling	SUPPL	83	AP	1978-05-22
LABELING; Labeling	SUPPL	84	AP	1977-06-09
LABELING; Labeling	SUPPL	85	AP	1977-10-14
LABELING; Labeling	SUPPL	86	AP	1977-12-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	87	AP	1978-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	88	AP	1978-05-23
LABELING; Labeling	SUPPL	89	AP	1978-05-23
LABELING; Labeling	SUPPL	90	AP	1978-07-25
LABELING; Labeling	SUPPL	91	AP	1978-08-10
LABELING; Labeling	SUPPL	92	AP	1978-08-17
LABELING; Labeling	SUPPL	93	AP	1978-08-22
LABELING; Labeling	SUPPL	94	AP	1978-08-28
LABELING; Labeling	SUPPL	95	AP	1978-09-29
LABELING; Labeling	SUPPL	96	AP	1978-10-18
LABELING; Labeling	SUPPL	97	AP	1978-11-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	98	AP	1978-11-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	99	AP	1979-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	101	AP	1979-05-15
LABELING; Labeling	SUPPL	103	AP	1980-02-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	104	AP	1980-03-05
LABELING; Labeling	SUPPL	105	AP	1980-07-17
LABELING; Labeling	SUPPL	106	AP	1981-01-27
LABELING; Labeling	SUPPL	107	AP	1981-02-11
LABELING; Labeling	SUPPL	108	AP	1981-03-12
LABELING; Labeling	SUPPL	109	AP	1981-06-19
LABELING; Labeling	SUPPL	110	AP	1981-04-08
LABELING; Labeling	SUPPL	111	AP	1981-06-10
LABELING; Labeling	SUPPL	112	AP	1981-07-23
LABELING; Labeling	SUPPL	113	AP	1981-08-11
LABELING; Labeling	SUPPL	114	AP	1981-09-01
LABELING; Labeling	SUPPL	115	AP	1981-09-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	116	AP	1981-11-27
LABELING; Labeling	SUPPL	117	AP	1982-01-04
LABELING; Labeling	SUPPL	118	AP	1982-02-19
LABELING; Labeling	SUPPL	119	AP	1982-03-08
LABELING; Labeling	SUPPL	120	AP	1982-04-20
LABELING; Labeling	SUPPL	121	AP	1982-05-05
LABELING; Labeling	SUPPL	122	AP	1982-05-12
LABELING; Labeling	SUPPL	123	AP	1982-05-18
LABELING; Labeling	SUPPL	124	AP	1982-06-04
LABELING; Labeling	SUPPL	125	AP	1982-06-28
LABELING; Labeling	SUPPL	126	AP	1982-07-12
LABELING; Labeling	SUPPL	127	AP	1982-07-12
LABELING; Labeling	SUPPL	128	AP	1982-09-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	129	AP	1992-05-29
LABELING; Labeling	SUPPL	130	AP	1992-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	132	AP	1994-01-04
LABELING; Labeling	SUPPL	133	AP	1999-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	134	AP	2002-05-21
LABELING; Labeling	SUPPL	135	AP	2004-01-15	STANDARD
LABELING; Labeling	SUPPL	138	AP	2005-01-06	STANDARD
LABELING; Labeling	SUPPL	139	AP	2004-06-02	STANDARD

Submissions Property Types

SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	48	Null	0
SUPPL	50	Null	0
SUPPL	52	Null	0
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	67	Null	0
SUPPL	68	Null	0
SUPPL	69	Null	0
SUPPL	72	Null	0
SUPPL	73	Null	0
SUPPL	74	Null	0
SUPPL	75	Null	0
SUPPL	76	Null	0
SUPPL	79	Null	0
SUPPL	87	Null	0
SUPPL	88	Null	0
SUPPL	98	Null	0
SUPPL	99	Null	0
SUPPL	101	Null	0
SUPPL	104	Null	0
SUPPL	116	Null	0
SUPPL	129	Null	0
SUPPL	132	Null	0
SUPPL	134	Null	0
SUPPL	139	Null	31

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50461
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANCEF","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 250MG BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ANCEF","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ANCEF","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 1GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ANCEF","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 5GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ANCEF","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 10GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/02\/2004","submission":"SUPPL-139","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50461slr139_ancef_lbl.pdf\"}]","notes":""},{"actionDate":"01\/15\/2004","submission":"SUPPL-135","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50461slr135_ancef_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ANCEF","submission":"CEFAZOLIN SODIUM","actionType":"EQ 250MG BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ANCEF","submission":"CEFAZOLIN SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ANCEF","submission":"CEFAZOLIN SODIUM","actionType":"EQ 1GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ANCEF","submission":"CEFAZOLIN SODIUM","actionType":"EQ 5GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ANCEF","submission":"CEFAZOLIN SODIUM","actionType":"EQ 10GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2004-06-02
        )

)

NDA 050461

GLAXOSMITHKLINE

FDA Drug Application

Application #050461

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

GLAXOSMITHKLINE