NDA 020756

WATSON LABS INC

FDA Drug Application

Application #020756

Documents

• Letter: 2001-04-11
• Letter: 2001-04-23
• Letter: 2003-09-29
• Review: 2003-08-07

Application Sponsors

NDA 020756

WATSON LABS INC

Marketing Status

• Prescription: 001

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
        )

)