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FDA ANDA · ANDA080737

CYANOCOBALAMIN

Sponsor: AM REGENT

APPLICATION
ANDA080737
TYPE
ANDA
ORIGINAL APPROVAL
1972-04-26
LATEST ACTION
2021-05-24
ROUTE
SUBCUTANEOUS, INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CYANOCOBALAMIN · ReferencePrescription
CYANOCOBALAMIN 1MG/ML · INJECTABLE · INJECTION

Approval history

2021-05-24Manufacturing (CMC) · Supplement 40 · unknown — Letter ↗AP
2002-06-27Manufacturing (CMC) · Supplement 22AP
2002-06-27Manufacturing (CMC) · Supplement 23AP
2001-05-14Manufacturing (CMC) · Supplement 20AP
2001-05-14Labeling · Supplement 21AP
2001-02-21Manufacturing (CMC) · Supplement 19AP
2000-09-11Manufacturing (CMC) · Supplement 17AP
1999-11-19Manufacturing (CMC) · Supplement 18AP
1997-10-30Manufacturing (CMC) · Supplement 16AP
1996-09-17Manufacturing (CMC) · Supplement 14AP
1996-09-17Labeling · Supplement 15AP
1996-02-28Manufacturing (CMC) · Supplement 13AP
1992-07-29Manufacturing (CMC) · Supplement 10AP
1992-07-29Manufacturing (CMC) · Supplement 11AP
1989-11-28Labeling · Supplement 12AP
1988-10-20Labeling · Supplement 9AP
1988-10-20Labeling · Supplement 5AP
1986-01-17Manufacturing (CMC) · Supplement 8AP
1986-01-17Manufacturing (CMC) · Supplement 6AP
1986-01-17Manufacturing (CMC) · Supplement 7AP
1982-08-16Manufacturing (CMC) · Supplement 3AP
1972-04-26OriginalAP
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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