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FDA NDA · NDA050316

LINCOCIN

Sponsor: PHARMACIA AND UPJOHN

APPLICATION
NDA050316
TYPE
NDA
ORIGINAL APPROVAL
1964-12-29
LATEST ACTION
2004-06-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

LINCOCINDiscontinued
LINCOMYCIN HYDROCHLORIDE EQ 500MG BASE · CAPSULE · ORAL
LINCOCINDiscontinued
LINCOMYCIN HYDROCHLORIDE EQ 250MG BASE · CAPSULE · ORAL

Approval history

2004-06-02Labeling · Supplement 99 · standardLetterAP
2001-10-30Manufacturing (CMC) · Supplement 98AP
1998-10-28Labeling · Supplement 6AP
1993-02-18Manufacturing (CMC) · Supplement 8AP
1991-08-29Labeling · Supplement 7AP
1985-06-21Labeling · Supplement 96AP
1985-06-03Labeling · Supplement 95AP
1982-11-20Labeling · Supplement 94AP
1982-08-03Manufacturing (CMC) · Supplement 93AP
1982-03-05Labeling · Supplement 92AP
1981-09-04Manufacturing (CMC) · Supplement 91AP
1980-11-19Manufacturing (CMC) · Supplement 90AP
1980-10-15Labeling · Supplement 89AP
1980-08-06Manufacturing (CMC) · Supplement 88AP
1979-06-20Manufacturing (CMC) · Supplement 87AP
1979-04-26Labeling · Supplement 86AP
1979-03-30Labeling · Supplement 85AP
1978-07-10Labeling · Supplement 84AP
1978-06-26Manufacturing (CMC) · Supplement 83AP
1978-02-27Labeling · Supplement 82AP
1977-06-29Manufacturing (CMC) · Supplement 81AP
1977-03-29Labeling · Supplement 80AP
1976-08-16Labeling · Supplement 79AP
1976-07-09Labeling · Supplement 75AP
1976-04-21Labeling · Supplement 78AP
1975-12-29Manufacturing (CMC) · Supplement 77AP
1975-11-12Labeling · Supplement 76AP
1975-03-14Labeling · Supplement 74AP
1974-08-26Labeling · Supplement 73AP
1974-08-09Labeling · Supplement 72AP
1974-08-06Labeling · Supplement 70AP
1974-08-06Labeling · Supplement 69AP
1974-08-06Manufacturing (CMC) · Supplement 71AP
1974-01-29Labeling · Supplement 68AP
1973-11-15Labeling · Supplement 67AP
1973-05-10Labeling · Supplement 66AP
1973-03-15Manufacturing (CMC) · Supplement 65AP
1972-09-05Labeling · Supplement 63AP
1972-07-31Manufacturing (CMC) · Supplement 62AP
1972-06-06Labeling · Supplement 61AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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