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FDA ANDA · ANDA214390

CYANOCOBALAMIN

Sponsor: GLAND

APPLICATION
ANDA214390
TYPE
ANDA
ORIGINAL APPROVAL
2020-09-24
LATEST ACTION
2025-01-10
ROUTE
INTRAMUSCULAR, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CYANOCOBALAMINPrescription
CYANOCOBALAMIN 1MG/ML · INJECTABLE · INJECTION

Approval history

2025-01-10Labeling · Supplement 3 · standardAP
2022-10-14Manufacturing (CMC) · Supplement 1 · unknownLetterAP
2022-10-14Labeling · Supplement 2 · standardAP
2020-09-24UNKNOWN · Original · standardAP
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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