FDA BLA · BLA103532

PULMOZYME

dornase alfa

Sponsor: GENENTECH

APPLICATION

BLA103532

TYPE

BLA

ORIGINAL APPROVAL

1993-12-30

LATEST ACTION

2024-02-09

ROUTE

RESPIRATORY (INHALATION)

DOSAGE FORM

VIAL

MARKETING STATUS

Prescription

Products

PULMOZYMEPrescription

DORNASE ALFA 1MG/ML · VIAL

2024-02-09Labeling · Supplement 5194 · standard — Label ↗AP

2021-07-30Labeling · Supplement 5191 · standard — Letter ↗AP

2014-12-12Efficacy · Supplement 5175 · standard — Letter ↗AP

2010-10-06Labeling · Supplement 5142 · standardAP

1999-12-20Labeling · Supplement 1030 · standardAP

1998-02-24Efficacy · Supplement 1025 · standardAP

1996-11-27Efficacy · Supplement 1018 · unknownAP

1993-12-30Type 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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