NDA 050317

PHARMACIA AND UPJOHN

FDA Drug Application

Application #050317

Documents

• Letter: 2004-06-07
• Letter: 2014-10-21
• Label: 2014-10-16
• Letter: 2008-02-29
• Label: 2008-02-28
• Letter: 2016-11-10
• Letter: 2016-11-10
• Label: 2016-11-10
• Label: 2016-11-10
• Letter: 2018-04-02
• Label: 2018-04-02
• Label: 2018-11-20
• Letter: 2018-12-07
• Letter: 2022-04-12
• Label: 2022-04-12

Application Sponsors

NDA 050317

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 300MG BASE/ML

1

LINCOCIN

LINCOMYCIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1964-12-29	UNKNOWN
LABELING; Labeling	SUPPL	2	AP	1982-10-20
LABELING; Labeling	SUPPL	3	AP	1982-10-28
LABELING; Labeling	SUPPL	4	AP	1982-11-15
LABELING; Labeling	SUPPL	5	AP	1982-11-23
LABELING; Labeling	SUPPL	6	AP	1984-11-19
LABELING; Labeling	SUPPL	7	AP	1985-06-03
LABELING; Labeling	SUPPL	8	AP	1985-06-21
LABELING; Labeling	SUPPL	9	AP	1986-06-04
LABELING; Labeling	SUPPL	11	AP	1990-03-22
LABELING; Labeling	SUPPL	12	AP	1998-10-28
LABELING; Labeling	SUPPL	13	AP	1991-08-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1993-01-15
LABELING; Labeling	SUPPL	15	AP	1965-04-14
LABELING; Labeling	SUPPL	16	AP	1965-06-07
LABELING; Labeling	SUPPL	17	AP	1965-10-06
LABELING; Labeling	SUPPL	18	AP	1991-07-16
LABELING; Labeling	SUPPL	19	AP	1965-08-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1965-09-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1965-11-10
LABELING; Labeling	SUPPL	22	AP	1965-09-29
LABELING; Labeling	SUPPL	23	AP	1966-01-14
LABELING; Labeling	SUPPL	25	AP	1966-10-31
LABELING; Labeling	SUPPL	26	AP	1966-10-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1967-12-26
LABELING; Labeling	SUPPL	28	AP	1966-12-22
LABELING; Labeling	SUPPL	30	AP	1967-04-14
LABELING; Labeling	SUPPL	31	AP	1967-04-17
LABELING; Labeling	SUPPL	32	AP	1967-04-26
LABELING; Labeling	SUPPL	33	AP	1967-04-26
LABELING; Labeling	SUPPL	34	AP	1967-06-30
LABELING; Labeling	SUPPL	35	AP	1967-07-14
LABELING; Labeling	SUPPL	36	AP	1967-07-26
LABELING; Labeling	SUPPL	37	AP	1967-08-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1967-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1967-12-26
LABELING; Labeling	SUPPL	40	AP	1967-12-14
LABELING; Labeling	SUPPL	41	AP	1967-12-26
LABELING; Labeling	SUPPL	42	AP	1968-01-22
LABELING; Labeling	SUPPL	43	AP	1968-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1968-01-23
LABELING; Labeling	SUPPL	45	AP	1968-01-30
LABELING; Labeling	SUPPL	46	AP	1968-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1968-03-12
LABELING; Labeling	SUPPL	48	AP	1968-03-08
LABELING; Labeling	SUPPL	49	AP	1968-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1968-04-03
LABELING; Labeling	SUPPL	52	AP	1968-04-10
LABELING; Labeling	SUPPL	53	AP	1968-04-24
LABELING; Labeling	SUPPL	54	AP	1968-05-27
LABELING; Labeling	SUPPL	55	AP	1968-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	1968-06-11
LABELING; Labeling	SUPPL	57	AP	1968-07-24
LABELING; Labeling	SUPPL	61	AP	1969-03-04
LABELING; Labeling	SUPPL	62	AP	1969-03-04
LABELING; Labeling	SUPPL	63	AP	1969-03-04
LABELING; Labeling	SUPPL	64	AP	1969-04-10
LABELING; Labeling	SUPPL	65	AP	1969-06-03
LABELING; Labeling	SUPPL	66	AP	1969-06-27
LABELING; Labeling	SUPPL	67	AP	1969-06-27
LABELING; Labeling	SUPPL	69	AP	1970-03-11
LABELING; Labeling	SUPPL	70	AP	1970-04-02
LABELING; Labeling	SUPPL	71	AP	1970-04-14
LABELING; Labeling	SUPPL	72	AP	1970-04-21
LABELING; Labeling	SUPPL	73	AP	1970-06-30
LABELING; Labeling	SUPPL	74	AP	1970-07-08
LABELING; Labeling	SUPPL	75	AP	1970-08-06
LABELING; Labeling	SUPPL	76	AP	1970-10-29
LABELING; Labeling	SUPPL	77	AP	1970-11-05
LABELING; Labeling	SUPPL	78	AP	1970-12-10
LABELING; Labeling	SUPPL	79	AP	1970-12-15
LABELING; Labeling	SUPPL	80	AP	1971-01-19
LABELING; Labeling	SUPPL	81	AP	1971-02-16
LABELING; Labeling	SUPPL	82	AP	1971-02-19
LABELING; Labeling	SUPPL	83	AP	1971-06-01
LABELING; Labeling	SUPPL	84	AP	1971-04-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	85	AP	1971-06-01
LABELING; Labeling	SUPPL	86	AP	1971-08-04
LABELING; Labeling	SUPPL	87	AP	1971-06-29
LABELING; Labeling	SUPPL	88	AP	1971-08-05
LABELING; Labeling	SUPPL	89	AP	1971-08-10
LABELING; Labeling	SUPPL	90	AP	1971-08-19
LABELING; Labeling	SUPPL	91	AP	1971-08-25
LABELING; Labeling	SUPPL	92	AP	1971-10-04
LABELING; Labeling	SUPPL	93	AP	1971-10-14
LABELING; Labeling	SUPPL	94	AP	1971-11-03
LABELING; Labeling	SUPPL	95	AP	1971-11-22
LABELING; Labeling	SUPPL	96	AP	1971-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	97	AP	1971-12-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	98	AP	1972-01-25
LABELING; Labeling	SUPPL	99	AP	1972-01-31
LABELING; Labeling	SUPPL	100	AP	1972-02-09
LABELING; Labeling	SUPPL	101	AP	1972-03-06
LABELING; Labeling	SUPPL	102	AP	1972-04-10
LABELING; Labeling	SUPPL	103	AP	1972-05-04
LABELING; Labeling	SUPPL	104	AP	1972-05-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	105	AP	1972-06-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	106	AP	1972-08-03
LABELING; Labeling	SUPPL	107	AP	1972-08-11
LABELING; Labeling	SUPPL	108	AP	1972-08-22
LABELING; Labeling	SUPPL	109	AP	1972-10-02
LABELING; Labeling	SUPPL	110	AP	1972-10-06
LABELING; Labeling	SUPPL	111	AP	1972-10-11
LABELING; Labeling	SUPPL	112	AP	1972-11-17
LABELING; Labeling	SUPPL	113	AP	1972-11-24
LABELING; Labeling	SUPPL	114	AP	1973-01-30
LABELING; Labeling	SUPPL	115	AP	1973-02-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	116	AP	1973-03-06
LABELING; Labeling	SUPPL	117	AP	1973-05-07
LABELING; Labeling	SUPPL	118	AP	1973-07-13
LABELING; Labeling	SUPPL	119	AP	1973-12-07
LABELING; Labeling	SUPPL	120	AP	1973-12-11
LABELING; Labeling	SUPPL	121	AP	1974-01-29
LABELING; Labeling	SUPPL	122	AP	1974-04-09
LABELING; Labeling	SUPPL	123	AP	1974-04-24
LABELING; Labeling	SUPPL	124	AP	1974-06-06
LABELING; Labeling	SUPPL	125	AP	1974-06-17
LABELING; Labeling	SUPPL	126	AP	1974-08-09
LABELING; Labeling	SUPPL	127	AP	1974-08-09
LABELING; Labeling	SUPPL	128	AP	1974-08-26
LABELING; Labeling	SUPPL	129	AP	1974-11-19
LABELING; Labeling	SUPPL	130	AP	1974-11-19
LABELING; Labeling	SUPPL	132	AP	1975-05-30
LABELING; Labeling	SUPPL	133	AP	1975-07-03
LABELING; Labeling	SUPPL	134	AP	1975-10-09
LABELING; Labeling	SUPPL	135	AP	1975-12-02
LABELING; Labeling	SUPPL	136	AP	1975-12-29
LABELING; Labeling	SUPPL	137	AP	1976-07-26
LABELING; Labeling	SUPPL	138	AP	1976-08-10
LABELING; Labeling	SUPPL	139	AP	1976-12-07
LABELING; Labeling	SUPPL	140	AP	1978-02-27
LABELING; Labeling	SUPPL	141	AP	1977-03-29
LABELING; Labeling	SUPPL	142	AP	1977-06-24
LABELING; Labeling	SUPPL	143	AP	1978-06-26
LABELING; Labeling	SUPPL	144	AP	1978-07-10
LABELING; Labeling	SUPPL	145	AP	1979-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	146	AP	1979-02-27
LABELING; Labeling	SUPPL	147	AP	1979-03-22
LABELING; Labeling	SUPPL	148	AP	1979-06-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	149	AP	1979-08-24
LABELING; Labeling	SUPPL	150	AP	1980-04-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	151	AP	1980-07-30
LABELING; Labeling	SUPPL	152	AP	1980-09-09
LABELING; Labeling	SUPPL	153	AP	1980-10-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	154	AP	1980-12-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	155	AP	1981-09-17
LABELING; Labeling	SUPPL	157	AP	1982-08-03
LABELING; Labeling	SUPPL	158	AP	1982-09-08
LABELING; Labeling	SUPPL	161	AP	1987-04-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	162	AP	2000-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	163	AP	2001-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	164	AP	2002-10-17
LABELING; Labeling	SUPPL	167	AP	2004-06-02	STANDARD
LABELING; Labeling	SUPPL	172	AP	2008-02-27	STANDARD
LABELING; Labeling	SUPPL	177	AP	2014-10-15	STANDARD
LABELING; Labeling	SUPPL	179	AP	2016-11-08	STANDARD
LABELING; Labeling	SUPPL	180	AP	2016-11-08	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	183	AP	2018-11-16	STANDARD
LABELING; Labeling	SUPPL	184	AP	2018-04-01	STANDARD
LABELING; Labeling	SUPPL	187	AP	2022-04-11	STANDARD

Submissions Property Types

SUPPL	14	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	27	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	44	Null	0
SUPPL	47	Null	0
SUPPL	51	Null	0
SUPPL	56	Null	0
SUPPL	85	Null	0
SUPPL	97	Null	0
SUPPL	98	Null	0
SUPPL	105	Null	0
SUPPL	106	Null	0
SUPPL	116	Null	0
SUPPL	146	Null	0
SUPPL	149	Null	0
SUPPL	151	Null	0
SUPPL	154	Null	0
SUPPL	155	Null	0
SUPPL	162	Null	0
SUPPL	163	Null	0
SUPPL	164	Null	0
SUPPL	177	Null	7
SUPPL	179	Null	6
SUPPL	180	Null	6
SUPPL	183	Null	15
SUPPL	184	Null	15
SUPPL	187	Null	7

TE Codes

001

Prescription

AP

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50317
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINCOCIN","activeIngredients":"LINCOMYCIN HYDROCHLORIDE","strength":"EQ 300MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/16\/2018","submission":"SUPPL-183","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050317s183lbl.pdf\"}]","notes":""},{"actionDate":"04\/01\/2018","submission":"SUPPL-184","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050317s184lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2016","submission":"SUPPL-180","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050317s179s180lbl.pdf\"}]","notes":"Please see"},{"actionDate":"11\/08\/2016","submission":"SUPPL-179","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050317s179s180lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2014","submission":"SUPPL-177","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050317s177lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2008","submission":"SUPPL-172","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050317s172lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LINCOCIN","submission":"LINCOMYCIN HYDROCHLORIDE","actionType":"EQ 300MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-11-16
        )

)