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FDA ANDA · ANDA080573

CYANOCOBALAMIN

Sponsor: DR REDDYS

APPLICATION
ANDA080573
TYPE
ANDA
ORIGINAL APPROVAL
1974-01-29
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CYANOCOBALAMINDiscontinued
CYANOCOBALAMIN 0.1MG/ML · INJECTABLE · INJECTION
CYANOCOBALAMINDiscontinued
CYANOCOBALAMIN 1MG/ML · INJECTABLE · INJECTION

Approval history

1999-02-19Manufacturing (CMC) · Supplement 627AP
1999-02-02Manufacturing (CMC) · Supplement 626AP
1996-12-04Manufacturing (CMC) · Supplement 625AP
1993-11-04Labeling · Supplement 624AP
1991-11-12Manufacturing (CMC) · Supplement 622AP
1991-11-12Manufacturing (CMC) · Supplement 620AP
1991-11-12Manufacturing (CMC) · Supplement 619AP
1991-11-12Labeling · Supplement 623AP
1991-11-12Manufacturing (CMC) · Supplement 621AP
1991-04-15Manufacturing (CMC) · Supplement 617AP
1991-04-15Manufacturing (CMC) · Supplement 618AP
1991-04-15Manufacturing (CMC) · Supplement 616AP
1989-11-03Manufacturing (CMC) · Supplement 614AP
1988-12-21Manufacturing (CMC) · Supplement 613AP
1988-08-03Manufacturing (CMC) · Supplement 610AP
1988-08-03Manufacturing (CMC) · Supplement 611AP
1986-08-06Manufacturing (CMC) · Supplement 608AP
1985-02-01Manufacturing (CMC) · Supplement 607AP
1984-02-16Manufacturing (CMC) · Supplement 605AP
1983-01-27Manufacturing (CMC) · Supplement 604AP
1974-01-29OriginalAP
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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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