Documents
Application Sponsors
| NDA 021212 | PHARMACIA AND UPJOHN | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 0.01MG/VIAL | 0 | CAVERJECT IMPULSE | ALPROSTADIL |
| 002 | INJECTABLE;INJECTION | 0.02MG/VIAL | 0 | CAVERJECT IMPULSE | ALPROSTADIL |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2002-06-11 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2003-09-02 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2013-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2014-06-11 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2015-10-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2015-01-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2016-12-01 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2016-05-05 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2016-10-25 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2016-10-25 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2022-12-23 | STANDARD |
Submissions Property Types
| SUPPL | 7 | Null | 15 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 18 | Null | 6 |
CDER Filings
PFIZER
cder:Array
(
[0] => Array
(
[ApplNo] => 21212
[companyName] => PFIZER
[docInserts] => ["",""]
[products] => [{"drugName":"CAVERJECT IMPULSE","activeIngredients":"ALPROSTADIL","strength":"0.01MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CAVERJECT IMPULSE","activeIngredients":"ALPROSTADIL","strength":"0.02MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"10\/25\/2016","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021212s015s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2016","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021212s015s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2016","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021212s014lbl.pdf\"}]","notes":""},{"actionDate":"10\/27\/2015","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021212s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2013","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021212s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21212lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CAVERJECT IMPULSE","submission":"ALPROSTADIL","actionType":"0.01MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CAVERJECT IMPULSE","submission":"ALPROSTADIL","actionType":"0.02MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2016-10-25
)
)