Documents
Application Sponsors
| NDA 018925 | EXELA PHARMA SCS LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION;INTRAVENOUS | 5MG/2ML (2.5MG/ML) | 0 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE |
| 002 | SOLUTION;INTRAVENOUS | 10MG/4ML (2.5MG/ML) | 0 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1984-03-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1985-02-21 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1986-09-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1986-09-16 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1986-09-15 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1988-10-25 | |
| LABELING; Labeling | SUPPL | 7 | AP | 2010-04-13 | UNKNOWN |
| LABELING; Labeling | SUPPL | 8 | AP | 2011-11-02 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2016-04-08 | N/A |
| LABELING; Labeling | SUPPL | 10 | AP | 2016-11-18 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 7 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
EXELA PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 18925
[companyName] => EXELA PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"5MG\/2ML (2.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"10MG\/4ML (2.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"11\/18\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018925s010lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2011","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018925s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2010","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/018925s007,019038s003lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"VERAPAMIL HYDROCHLORIDE","submission":"VERAPAMIL HYDROCHLORIDE","actionType":"5MG\/2ML (2.5MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"VERAPAMIL HYDROCHLORIDE","submission":"VERAPAMIL HYDROCHLORIDE","actionType":"10MG\/4ML (2.5MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2016-11-18
)
)