FDA BLA · BLA103362

LEUKINE

sargramostim

Sponsor: BERLEX LABS

APPLICATION

BLA103362

TYPE

BLA

ORIGINAL APPROVAL

1991-03-05

LATEST ACTION

2022-05-05

ROUTE

INTRAVENOUS, SUBCUTANEOUS

DOSAGE FORM

VIAL

MARKETING STATUS

Prescription

Products

LEUKINEPrescription

SARGRAMOSTIM 250UG/ML · VIAL

LEUKINEPrescription

SARGRAMOSTIM 500UG/ML · VIAL

2022-05-05Labeling · Supplement 5249 · standard — Letter ↗AP

2018-03-29Efficacy · Supplement 5240 · priority — Label ↗AP

2017-02-10Labeling · Supplement 5237 · standard — Letter ↗AP

2008-11-04Labeling · Supplement 5140 · standardAP

2002-03-14Labeling · Supplement 5012 · standardAP

1995-12-22Efficacy · Supplement 1045 · unknownAP

1995-11-24Efficacy · Supplement 1048 · unknownAP

1995-09-15Efficacy · Supplement 1033 · unknownAP

1991-03-05Type 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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