Application Sponsors
NDA 016119 | BRISTOL MYERS SQUIBB | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 100MG/ML | 0 | TESLAC | TESTOLACTONE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1969-06-03 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1976-07-06 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1978-06-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1978-01-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1977-12-22 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1979-10-11 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1979-04-27 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 16119
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"TESLAC","activeIngredients":"TESTOLACTONE","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TESLAC","submission":"TESTOLACTONE","actionType":"100MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)