Documents
Application Sponsors
| NDA 020379 | PHARMACIA AND UPJOHN | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Discontinued | 003 |
| Prescription | 004 |
Application Products
| 001 | INJECTABLE;INJECTION | 0.01MG/VIAL | 1 | CAVERJECT | ALPROSTADIL |
| 002 | INJECTABLE;INJECTION | 0.02MG/VIAL | 1 | CAVERJECT | ALPROSTADIL |
| 003 | INJECTABLE;INJECTION | 0.005MG/VIAL | 1 | CAVERJECT | ALPROSTADIL |
| 004 | INJECTABLE;INJECTION | 0.04MG/VIAL | 1 | CAVERJECT | ALPROSTADIL |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1995-07-06 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1996-05-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-06-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 1996-06-28 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1996-10-21 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1997-10-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1997-05-19 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1998-05-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 1998-03-26 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 1999-01-20 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2002-01-15 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 1999-07-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2000-11-29 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-04-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-03-29 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2002-10-15 | PRIORITY |
| LABELING; Labeling | SUPPL | 17 | AP | 2003-09-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2016-02-08 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2014-03-28 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2014-06-09 | PRIORITY |
| LABELING; Labeling | SUPPL | 28 | AP | 2014-06-12 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2016-05-05 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2017-12-06 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2017-12-06 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2017-12-06 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2022-12-23 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 30 | Null | 6 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 32 | Null | 7 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 38 | Null | 6 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
| 004 | Prescription | AP |
CDER Filings
PFIZER
cder:Array
(
[0] => Array
(
[ApplNo] => 20379
[companyName] => PFIZER
[docInserts] => ["",""]
[products] => [{"drugName":"CAVERJECT","activeIngredients":"ALPROSTADIL","strength":"0.01MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CAVERJECT","activeIngredients":"ALPROSTADIL","strength":"0.02MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"CAVERJECT","activeIngredients":"ALPROSTADIL","strength":"0.005MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"CAVERJECT","activeIngredients":"ALPROSTADIL","strength":"0.04MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"12\/06\/2017","submission":"SUPPL-34","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020379s034lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2017","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020379s032lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2017","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020379s031lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2016","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020379s030lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2014","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020379s028lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CAVERJECT","submission":"ALPROSTADIL","actionType":"0.01MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CAVERJECT","submission":"ALPROSTADIL","actionType":"0.02MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CAVERJECT","submission":"ALPROSTADIL","actionType":"0.005MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CAVERJECT","submission":"ALPROSTADIL","actionType":"0.04MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-12-06
)
)