BLA 103532

GENENTECH

FDA Drug Application

Application #103532

Documents

• Letter: 2014-12-15
• Label: 2014-12-15
• Letter: 2021-08-02
• Label: 2021-08-03

Application Sponsors

BLA 103532

GENENTECH

Marketing Status

• Prescription: 001

Application Products

001

VIAL

1MG/ML

0

PULMOZYME

DORNASE ALFA

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1993-12-30	PRIORITY
EFFICACY; Efficacy	SUPPL	1018	AP	1996-11-27	UNKNOWN
EFFICACY; Efficacy	SUPPL	1025	AP	1998-02-24	STANDARD
LABELING; Labeling	SUPPL	1030	AP	1999-12-20	STANDARD
LABELING; Labeling	SUPPL	5142	AP	2010-10-06	STANDARD
EFFICACY; Efficacy	SUPPL	5175	AP	2014-12-12	STANDARD
LABELING; Labeling	SUPPL	5191	AP	2021-07-30	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	5175	Null	6
SUPPL	5191	Null	7

CDER Filings

GENENTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 103532
            [companyName] => GENENTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"PULMOZYME","activeIngredients":"DORNASE ALFA","strength":"1MG\/ML","dosageForm":"VIAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/12\/2014","submission":"SUPPL-5175","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103532s5175lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/30\/1993","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/12\/2014","submission":"SUPPL-5175","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103532s5175lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103532Orig1s5175ltr.pdf\"}]","notes":">"},{"actionDate":"10\/06\/2010","submission":"SUPPL-5142","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/20\/1999","submission":"SUPPL-1030","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/24\/1998","submission":"SUPPL-1025","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/27\/1996","submission":"SUPPL-1018","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2014-12-12
        )

)