Documents
Application Sponsors
| BLA 021640 | BAUSCH AND LOMB | |
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 6,200 UNITS/VIAL | 0 | VITRASE | HYALURONIDASE |
| 002 | INJECTABLE;INJECTION | 200 UNITS/VIAL | 0 | VITRASE | HYALURONIDASE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2004-05-05 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2004-12-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2004-12-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 16 | AP | 2012-04-12 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2014-02-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2015-11-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2015-02-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 25 | AP | 2018-05-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 15 |
CDER Filings
BAUSCH AND LOMB
cder:Array
(
[0] => Array
(
[ApplNo] => 21640
[companyName] => BAUSCH AND LOMB
[docInserts] => ["",""]
[products] => [{"drugName":"VITRASE","activeIngredients":"HYALURONIDASE","strength":"6,200 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VITRASE","activeIngredients":"HYALURONIDASE","strength":"200 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"05\/25\/2018","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021640s025lbl.pdf\"}]","notes":""},{"actionDate":"04\/12\/2012","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021640s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2004","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21640s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2004","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21640s002,003lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2004","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21640s002,003lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21640_vitrase_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"VITRASE","submission":"HYALURONIDASE","actionType":"6,200 UNITS\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VITRASE","submission":"HYALURONIDASE","actionType":"200 UNITS\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2018-05-25
)
)