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FDA ANDA · ANDA062365

CHLORAMPHENICOL SODIUM SUCCINATE

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA062365
TYPE
ANDA
ORIGINAL APPROVAL
1982-08-25
LATEST ACTION
2016-08-01
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CHLORAMPHENICOL SODIUM SUCCINATEDiscontinued
CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2016-08-01Labeling · Supplement 18 · standardAP
2016-08-01Labeling · Supplement 20 · standardAP
2014-11-10Manufacturing (CMC) · Supplement 19AP
2002-12-05Manufacturing (CMC) · Supplement 12AP
2002-07-15Manufacturing (CMC) · Supplement 11AP
1993-04-08Labeling · Supplement 9AP
1992-12-15Labeling · Supplement 8AP
1992-09-10Labeling · Supplement 7AP
1988-11-23Manufacturing (CMC) · Supplement 6AP
1982-08-25OriginalAP
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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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