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FDA ANDA · ANDA061769

CEFADYL

Sponsor: APOTHECON

APPLICATION
ANDA061769
TYPE
ANDA
ORIGINAL APPROVAL
1974-03-12
LATEST ACTION
1993-06-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CEFADYLDiscontinued
CEPHAPIRIN SODIUM EQ 4GM BASE/VIAL · INJECTABLE · INJECTION
CEFADYLDiscontinued
CEPHAPIRIN SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
CEFADYLDiscontinued
CEPHAPIRIN SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

1993-06-11Labeling · Supplement 15AP
1992-01-13Manufacturing (CMC) · Supplement 4AP
1991-05-21Labeling · Supplement 14AP
1990-07-17Manufacturing (CMC) · Supplement 13AP
1988-12-01Manufacturing (CMC) · Supplement 12AP
1974-03-12OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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