NDA 050316

PHARMACIA AND UPJOHN

FDA Drug Application

Application #050316

Documents

• Letter: 2004-06-07

Application Sponsors

NDA 050316

PHARMACIA AND UPJOHN

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	CAPSULE;ORAL	EQ 250MG BASE	0	LINCOCIN	LINCOMYCIN HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 500MG BASE	0	LINCOCIN	LINCOMYCIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1964-12-29	UNKNOWN
LABELING; Labeling	SUPPL	6	AP	1998-10-28
LABELING; Labeling	SUPPL	7	AP	1991-08-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1993-02-18
LABELING; Labeling	SUPPL	9	AP	1966-05-10
LABELING; Labeling	SUPPL	10	AP	1966-11-28
LABELING; Labeling	SUPPL	12	AP	1966-12-22
LABELING; Labeling	SUPPL	13	AP	1966-12-15
LABELING; Labeling	SUPPL	14	AP	1966-12-28
LABELING; Labeling	SUPPL	15	AP	1967-02-01
LABELING; Labeling	SUPPL	16	AP	1967-05-19
LABELING; Labeling	SUPPL	17	AP	1967-06-30
LABELING; Labeling	SUPPL	18	AP	1967-07-20
LABELING; Labeling	SUPPL	19	AP	1967-08-09
LABELING; Labeling	SUPPL	20	AP	1967-08-16
LABELING; Labeling	SUPPL	21	AP	1967-08-22
LABELING; Labeling	SUPPL	22	AP	1967-10-16
LABELING; Labeling	SUPPL	23	AP	1967-10-27
LABELING; Labeling	SUPPL	24	AP	1967-12-19
LABELING; Labeling	SUPPL	25	AP	1968-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1968-03-11
LABELING; Labeling	SUPPL	27	AP	1968-04-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1968-07-12
LABELING; Labeling	SUPPL	29	AP	1970-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1969-02-28
LABELING; Labeling	SUPPL	31	AP	1969-03-03
LABELING; Labeling	SUPPL	32	AP	1969-04-10
LABELING; Labeling	SUPPL	33	AP	1969-06-09
LABELING; Labeling	SUPPL	34	AP	1969-06-27
LABELING; Labeling	SUPPL	35	AP	1970-01-22
LABELING; Labeling	SUPPL	37	AP	1970-03-03
LABELING; Labeling	SUPPL	38	AP	1970-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1970-04-01
LABELING; Labeling	SUPPL	40	AP	1970-05-25
LABELING; Labeling	SUPPL	41	AP	1970-06-05
LABELING; Labeling	SUPPL	42	AP	1970-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1970-08-21
LABELING; Labeling	SUPPL	44	AP	1970-08-07
LABELING; Labeling	SUPPL	45	AP	1970-09-04
LABELING; Labeling	SUPPL	46	AP	1970-09-10
LABELING; Labeling	SUPPL	47	AP	1970-11-18
LABELING; Labeling	SUPPL	48	AP	1970-12-09
LABELING; Labeling	SUPPL	49	AP	1971-02-08
LABELING; Labeling	SUPPL	50	AP	1971-02-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1971-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1971-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1971-05-27
LABELING; Labeling	SUPPL	54	AP	1971-10-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1971-07-22
LABELING; Labeling	SUPPL	56	AP	1971-09-23
LABELING; Labeling	SUPPL	57	AP	1971-09-27
LABELING; Labeling	SUPPL	58	AP	1971-10-14
LABELING; Labeling	SUPPL	61	AP	1972-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	1972-07-31
LABELING; Labeling	SUPPL	63	AP	1972-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	1973-03-15
LABELING; Labeling	SUPPL	66	AP	1973-05-10
LABELING; Labeling	SUPPL	67	AP	1973-11-15
LABELING; Labeling	SUPPL	68	AP	1974-01-29
LABELING; Labeling	SUPPL	69	AP	1974-08-06
LABELING; Labeling	SUPPL	70	AP	1974-08-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	71	AP	1974-08-06
LABELING; Labeling	SUPPL	72	AP	1974-08-09
LABELING; Labeling	SUPPL	73	AP	1974-08-26
LABELING; Labeling	SUPPL	74	AP	1975-03-14
LABELING; Labeling	SUPPL	75	AP	1976-07-09
LABELING; Labeling	SUPPL	76	AP	1975-11-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	77	AP	1975-12-29
LABELING; Labeling	SUPPL	78	AP	1976-04-21
LABELING; Labeling	SUPPL	79	AP	1976-08-16
LABELING; Labeling	SUPPL	80	AP	1977-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	81	AP	1977-06-29
LABELING; Labeling	SUPPL	82	AP	1978-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	83	AP	1978-06-26
LABELING; Labeling	SUPPL	84	AP	1978-07-10
LABELING; Labeling	SUPPL	85	AP	1979-03-30
LABELING; Labeling	SUPPL	86	AP	1979-04-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	87	AP	1979-06-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	88	AP	1980-08-06
LABELING; Labeling	SUPPL	89	AP	1980-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	90	AP	1980-11-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	91	AP	1981-09-04
LABELING; Labeling	SUPPL	92	AP	1982-03-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	93	AP	1982-08-03
LABELING; Labeling	SUPPL	94	AP	1982-11-20
LABELING; Labeling	SUPPL	95	AP	1985-06-03
LABELING; Labeling	SUPPL	96	AP	1985-06-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	98	AP	2001-10-30
LABELING; Labeling	SUPPL	99	AP	2004-06-02	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	8	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	39	Null	0
SUPPL	43	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	55	Null	0
SUPPL	62	Null	0
SUPPL	65	Null	0
SUPPL	71	Null	0
SUPPL	77	Null	0
SUPPL	81	Null	0
SUPPL	83	Null	0
SUPPL	87	Null	0
SUPPL	88	Null	0
SUPPL	90	Null	0
SUPPL	91	Null	0
SUPPL	93	Null	0
SUPPL	98	Null	0

CDER Filings

PHARMACIA AND UPJOHN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50316
            [companyName] => PHARMACIA AND UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINCOCIN","activeIngredients":"LINCOMYCIN HYDROCHLORIDE","strength":"EQ 250MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LINCOCIN","activeIngredients":"LINCOMYCIN HYDROCHLORIDE","strength":"EQ 500MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LINCOCIN","submission":"LINCOMYCIN HYDROCHLORIDE","actionType":"EQ 250MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LINCOCIN","submission":"LINCOMYCIN HYDROCHLORIDE","actionType":"EQ 500MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)