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FDA ANDA · ANDA089347

RENOCAL-76

Sponsor: BRACCO

APPLICATION
ANDA089347
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-01
LATEST ACTION
2002-02-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

RENOCAL-76Discontinued
DIATRIZOATE MEGLUMINE 66%, DIATRIZOATE SODIUM 10% · INJECTABLE · INJECTION

Approval history

2002-02-22Labeling · Supplement 8AP
2001-07-18Manufacturing (CMC) · Supplement 6AP
2001-07-18Manufacturing (CMC) · Supplement 7AP
2001-07-18Manufacturing (CMC) · Supplement 5AP
2001-07-18Manufacturing (CMC) · Supplement 3AP
1995-10-17Labeling · Supplement 2AP
1988-12-01Manufacturing (CMC) · Supplement 1AP
1988-06-01OriginalAP
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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