FDA NDA · NDA017084

PHOSPHOCOL P32

Sponsor: CURIUM

APPLICATION

NDA017084

TYPE

NDA

ORIGINAL APPROVAL

1974-09-23

LATEST ACTION

2009-05-22

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued

Products

PHOSPHOCOL P32Discontinued

CHROMIC PHOSPHATE P-32 5mCi/ML · INJECTABLE · INJECTION

2009-05-22Labeling · Supplement 17 · standard — Label ↗AP

2008-08-29Labeling · Supplement 16 · standard — Letter ↗AP

2001-08-28Manufacturing (CMC) · Supplement 15 · standardAP

1998-04-22Manufacturing (CMC) · Supplement 14 · standardAP

1994-09-30Manufacturing (CMC) · Supplement 13 · standardAP

1994-03-30Manufacturing (CMC) · Supplement 12 · standardAP

1990-05-10Manufacturing (CMC) · Supplement 11 · standardAP

1989-04-24Manufacturing (CMC) · Supplement 5 · standardAP

1983-03-31Manufacturing (CMC) · Supplement 8 · standardAP

1982-05-07Manufacturing (CMC) · Supplement 7 · standardAP

1977-08-23Manufacturing (CMC) · Supplement 4 · standardAP

1977-07-27Manufacturing (CMC) · Supplement 3 · standardAP

1977-04-29Manufacturing (CMC) · Supplement 2 · standardAP

1977-04-29Labeling · Supplement 1AP

1974-09-23Type 5 - New Formulation or New Manufacturer · 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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