Documents
Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE, LIPOSOMAL;INJECTION | 50MG/VIAL | 1 | AMBISOME | AMPHOTERICIN B |
FDA Submissions
TYPE 2; Type 2 - New Active Ingredient | ORIG | 1 | AP | 1997-08-11 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 2 | AP | 2000-06-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2000-03-16 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2000-02-29 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2000-06-26 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2000-07-13 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2001-05-11 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2001-12-04 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2002-03-06 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2002-03-27 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2002-06-14 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2002-09-06 | PRIORITY |
LABELING; Labeling | SUPPL | 14 | AP | 2003-09-16 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2008-10-08 | STANDARD |
LABELING; Labeling | SUPPL | 21 | AP | 2012-03-08 | UNKNOWN Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2014-09-16 | PRIORITY |
LABELING; Labeling | SUPPL | 31 | AP | 2020-05-12 | STANDARD |
LABELING; Labeling | SUPPL | 33 | TA | 2020-08-17 | STANDARD |
Submissions Property Types
ORIG | 1 | Orphan | 5 |
SUPPL | 3 | Null | 14 |
SUPPL | 4 | Null | 14 |
SUPPL | 5 | Null | 14 |
SUPPL | 6 | Null | 14 |
SUPPL | 7 | Null | 14 |
SUPPL | 8 | Null | 14 |
SUPPL | 9 | Null | 14 |
SUPPL | 10 | Null | 14 |
SUPPL | 11 | Null | 14 |
SUPPL | 12 | Null | 14 |
SUPPL | 21 | Null | 15 |
SUPPL | 23 | Null | 14 |
SUPPL | 31 | Null | 6 |
SUPPL | 33 | Null | 15 |
TE Codes
CDER Filings
ASTELLAS
cder:Array
(
[0] => Array
(
[ApplNo] => 50740
[companyName] => ASTELLAS
[docInserts] => ["",""]
[products] => [{"drugName":"AMBISOME","activeIngredients":"AMPHOTERICIN B","strength":"50MG\/VIAL","dosageForm":"INJECTABLE, LIPOSOMAL;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"05\/12\/2020","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050740Orig1s031lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2020","submission":"SUPPL-31","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050740Orig1s031lbl.pdf\"}]","notes":""},{"actionDate":"03\/08\/2012","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050740s021lbl.pdf\"}]","notes":"Please see"},{"actionDate":"10\/08\/2008","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050740s016lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2003","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/50740slr014_ambisome_lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2000","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/50740S2LBL.PDF\"}]","notes":""},{"actionDate":"01\/28\/2000","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2000\\\/50-740S001_AmBisome_prntlbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"AMBISOME","submission":"AMPHOTERICIN B","actionType":"50MG\/VIAL","submissionClassification":"INJECTABLE, LIPOSOMAL;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-05-12
)
)