FDA NDA · NDA019292

MD-76R

Sponsor: LIEBEL-FLARSHEIM

APPLICATION

NDA019292

TYPE

NDA

ORIGINAL APPROVAL

1989-09-29

LATEST ACTION

2017-04-05

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued

Products

MD-76R · ReferenceDiscontinued

DIATRIZOATE MEGLUMINE 66%, DIATRIZOATE SODIUM 10% · INJECTABLE · INJECTION

2017-04-05Labeling · Supplement 11 · standard — Label ↗AP

2015-07-06Labeling · Supplement 10 · 901 required — Label ↗AP

2013-05-10Manufacturing (CMC) · Supplement 9 · standardAP

1996-07-25Manufacturing (CMC) · Supplement 7 · standardAP

1995-01-13Labeling · Supplement 8 · standardAP

1992-12-04Manufacturing (CMC) · Supplement 5 · standardAP

1992-08-28Manufacturing (CMC) · Supplement 6 · standardAP

1992-08-11Labeling · Supplement 4AP

1990-06-04Manufacturing (CMC) · Supplement 1 · standardAP

1990-04-09Manufacturing (CMC) · Supplement 2 · standardAP

1990-03-30Manufacturing (CMC) · Supplement 3 · standardAP

1989-09-29Type 3 - New Dosage Form · Original · standardAP

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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