FDA BLA · BLA103575

REOPRO

Sponsor: CENTOCOR INC

APPLICATION

BLA103575

TYPE

BLA

ORIGINAL APPROVAL

1994-12-22

LATEST ACTION

2019-08-07

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

REOPROPrescription

ABCIXIMAB 2MG/ML · INJECTABLE · INJECTION

2019-08-07Labeling · Supplement 5318 · standard — Label ↗AP

2019-08-07Labeling · Supplement 5138 · standard — Letter ↗AP

2013-11-25Labeling · Supplement 5126 · standard — Label ↗AP

2003-11-21Supplement · Supplement 5022 — Letter ↗AP

2003-11-21Labeling · Supplement 5025 · standard — Letter ↗AP

2001-01-23Efficacy · Supplement 1015 · standardAP

1997-11-05Efficacy · Supplement 1008 · priority — Review ↗AP

1997-11-05Efficacy · Supplement 1010 · priority — Label ↗AP

1994-12-22Type 1 - New Molecular Entity · Original · priorityAP

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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