Documents
Application Sponsors
NDA 020756 | WATSON LABS INC | |
Marketing Status
Application Products
001 | GEL;VAGINAL | 8% | 1 | CRINONE | PROGESTERONE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1997-05-13 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1998-02-17 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1997-12-11 | PRIORITY |
LABELING; Labeling | SUPPL | 6 | AP | 1998-05-11 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1998-12-16 | PRIORITY |
LABELING; Labeling | SUPPL | 9 | AP | 2001-04-03 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2001-04-20 | PRIORITY |
LABELING; Labeling | SUPPL | 12 | AP | 2003-09-17 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 10 | Null | 0 |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 20756
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"CRINONE","activeIngredients":"PROGESTERONE","strength":"8%","dosageForm":"GEL;VAGINAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CRINONE","submission":"PROGESTERONE","actionType":"8%","submissionClassification":"GEL;VAGINAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)