ANDA 091229

SANDOZ INC

FDA Drug Application

Application #091229

Application Sponsors

ANDA 091229

SANDOZ INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004
• None (Tentative Approval): 005
• None (Tentative Approval): 006
• None (Tentative Approval): 007
• None (Tentative Approval): 008

Application Products

001	CAPSULE; ORAL	25MG	0	PREGABALIN	PREGABALIN
002	CAPSULE; ORAL	50MG	0	PREGABALIN	PREGABALIN
003	CAPSULE; ORAL	75MG	0	PREGABALIN	PREGABALIN
004	CAPSULE; ORAL	100MG	0	PREGABALIN	PREGABALIN
005	CAPSULE; ORAL	150MG	0	PREGABALIN	PREGABALIN
006	CAPSULE; ORAL	200MG	0	PREGABALIN	PREGABALIN
007	CAPSULE; ORAL	225MG	0	PREGABALIN	PREGABALIN
008	CAPSULE; ORAL	300MG	0	PREGABALIN	PREGABALIN

FDA Submissions

ORIG

1

TA

2012-12-31

Submissions Property Types

ORIG

1

Null

17

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91229
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"25MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"50MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"75MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"100MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"150MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"200MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"225MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"300MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PREGABALIN","submission":"PREGABALIN","actionType":"25MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"PREGABALIN","submission":"PREGABALIN","actionType":"50MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"PREGABALIN","submission":"PREGABALIN","actionType":"75MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"PREGABALIN","submission":"PREGABALIN","actionType":"100MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"PREGABALIN","submission":"PREGABALIN","actionType":"150MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"PREGABALIN","submission":"PREGABALIN","actionType":"200MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"PREGABALIN","submission":"PREGABALIN","actionType":"225MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"PREGABALIN","submission":"PREGABALIN","actionType":"300MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)