NDA 050261

COREPHARMA

FDA Drug Application

Application #050261

Documents

• Letter: 2003-12-22
• Letter: 2003-05-30
• Letter: 2003-12-22
• Letter: 2012-09-07
• Label: 2008-06-05
• Label: 2012-09-06
• Letter: 2008-04-25

Application Sponsors

NDA 050261

COREPHARMA

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	75MG	0	DECLOMYCIN	DEMECLOCYCLINE HYDROCHLORIDE
002	TABLET;ORAL	150MG	0	DECLOMYCIN	DEMECLOCYCLINE HYDROCHLORIDE
003	TABLET;ORAL	300MG	0	DECLOMYCIN	DEMECLOCYCLINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1964-09-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-06-21
LABELING; Labeling	SUPPL	3	AP	1965-02-10
LABELING; Labeling	SUPPL	5	AP	1986-10-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-12-17
LABELING; Labeling	SUPPL	11	AP	1991-11-20
LABELING; Labeling	SUPPL	14	AP	1965-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1965-05-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1965-05-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1965-09-24
LABELING; Labeling	SUPPL	18	AP	1965-08-19
EFFICACY; Efficacy	SUPPL	19	AP	1965-12-23
LABELING; Labeling	SUPPL	20	AP	1965-12-13
LABELING; Labeling	SUPPL	21	AP	1965-12-07
LABELING; Labeling	SUPPL	22	AP	1966-01-13
LABELING; Labeling	SUPPL	23	AP	1966-01-13
LABELING; Labeling	SUPPL	24	AP	1965-12-22
LABELING; Labeling	SUPPL	25	AP	1966-01-05
LABELING; Labeling	SUPPL	26	AP	1966-01-05
LABELING; Labeling	SUPPL	27	AP	1966-03-14
LABELING; Labeling	SUPPL	28	AP	1966-02-18
LABELING; Labeling	SUPPL	29	AP	1966-03-11
LABELING; Labeling	SUPPL	30	AP	1966-03-25
LABELING; Labeling	SUPPL	31	AP	1966-05-04
LABELING; Labeling	SUPPL	32	AP	1966-05-04
LABELING; Labeling	SUPPL	33	AP	1966-05-04
LABELING; Labeling	SUPPL	34	AP	1966-05-04
LABELING; Labeling	SUPPL	35	AP	1966-05-04
LABELING; Labeling	SUPPL	36	AP	1966-05-04
LABELING; Labeling	SUPPL	37	AP	1966-05-04
LABELING; Labeling	SUPPL	38	AP	1966-05-04
LABELING; Labeling	SUPPL	39	AP	1966-05-04
LABELING; Labeling	SUPPL	40	AP	1966-05-04
LABELING; Labeling	SUPPL	41	AP	1966-06-03
LABELING; Labeling	SUPPL	42	AP	1966-07-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1966-09-15
LABELING; Labeling	SUPPL	44	AP	1966-12-05
LABELING; Labeling	SUPPL	45	AP	1966-09-28
LABELING; Labeling	SUPPL	46	AP	1966-09-28
LABELING; Labeling	SUPPL	50	AP	1966-11-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1966-12-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1966-12-29
LABELING; Labeling	SUPPL	53	AP	1967-02-20
LABELING; Labeling	SUPPL	54	AP	1967-02-15
LABELING; Labeling	SUPPL	55	AP	1967-04-25
LABELING; Labeling	SUPPL	56	AP	1967-04-25
LABELING; Labeling	SUPPL	57	AP	1967-04-25
LABELING; Labeling	SUPPL	58	AP	1967-11-17
LABELING; Labeling	SUPPL	59	AP	1967-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	1969-01-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	61	AP	1970-04-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	1970-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	1970-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	64	AP	1970-12-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	1971-06-14
LABELING; Labeling	SUPPL	66	AP	1971-07-14
LABELING; Labeling	SUPPL	67	AP	1972-01-10
LABELING; Labeling	SUPPL	68	AP	1972-01-10
LABELING; Labeling	SUPPL	69	AP	1972-01-10
LABELING; Labeling	SUPPL	70	AP	1972-02-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	71	AP	1972-02-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	72	AP	1972-02-16
LABELING; Labeling	SUPPL	73	AP	1973-10-01
LABELING; Labeling	SUPPL	74	AP	1973-10-01
LABELING; Labeling	SUPPL	75	AP	1973-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	76	AP	1974-01-10
LABELING; Labeling	SUPPL	77	AP	1974-02-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	78	AP	1974-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	79	AP	1975-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	80	AP	1975-12-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	81	AP	1976-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	82	AP	1976-06-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	83	AP	1976-08-25
LABELING; Labeling	SUPPL	84	AP	1978-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	85	AP	1978-09-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	86	AP	1978-09-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	87	AP	1979-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	88	AP	1980-04-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	89	AP	1982-03-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	90	AP	1997-06-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	91	AP	1997-06-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	92	AP	1999-10-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	93	AP	2000-12-07
LABELING; Labeling	SUPPL	94	AP	2003-12-18
LABELING; Labeling	SUPPL	95	AP	2003-05-01
LABELING; Labeling	SUPPL	97	AP	2003-12-18
LABELING; Labeling	SUPPL	100	AP	2008-04-22
LABELING; Labeling	SUPPL	101	AP	2012-09-05

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	0
SUPPL	59	Null	0
SUPPL	60	Null	0
SUPPL	61	Null	0
SUPPL	62	Null	0
SUPPL	63	Null	0
SUPPL	64	Null	0
SUPPL	65	Null	0
SUPPL	66	Null	0
SUPPL	67	Null	0
SUPPL	68	Null	0
SUPPL	69	Null	0
SUPPL	70	Null	0
SUPPL	71	Null	0
SUPPL	72	Null	0
SUPPL	73	Null	0
SUPPL	74	Null	0
SUPPL	75	Null	0
SUPPL	76	Null	0
SUPPL	77	Null	0
SUPPL	78	Null	0
SUPPL	79	Null	0
SUPPL	80	Null	0
SUPPL	81	Null	0
SUPPL	82	Null	0
SUPPL	83	Null	0
SUPPL	84	Null	0
SUPPL	85	Null	0
SUPPL	86	Null	0
SUPPL	87	Null	0
SUPPL	88	Null	0
SUPPL	89	Null	0
SUPPL	90	Null	0
SUPPL	91	Null	0
SUPPL	92	Null	0
SUPPL	93	Null	0
SUPPL	94	Null	0
SUPPL	95	Null	0
SUPPL	97	Null	0
SUPPL	100	Null	0
SUPPL	101	Null	0

CDER Filings

COREPHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50261
            [companyName] => COREPHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DECLOMYCIN","activeIngredients":"DEMECLOCYCLINE HYDROCHLORIDE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DECLOMYCIN","activeIngredients":"DEMECLOCYCLINE HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DECLOMYCIN","activeIngredients":"DEMECLOCYCLINE HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/05\/2012","submission":"SUPPL-101","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050261s101lbl.pdf\"}]","notes":""},{"actionDate":"04\/22\/2008","submission":"SUPPL-100","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050261s100lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DECLOMYCIN","submission":"DEMECLOCYCLINE HYDROCHLORIDE","actionType":"75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DECLOMYCIN","submission":"DEMECLOCYCLINE HYDROCHLORIDE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DECLOMYCIN","submission":"DEMECLOCYCLINE HYDROCHLORIDE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2012-09-05
        )

)