ANDA 075347

ACTAVIS LABS FL INC

FDA Drug Application

Application #075347

Documents

• Letter: 2004-06-10
• Letter: 2001-11-16
• Review: 2004-12-07

Application Sponsors

ANDA 075347

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE, DELAYED REL PELLETS;ORAL	10MG	0	OMEPRAZOLE	OMEPRAZOLE
002	CAPSULE, DELAYED REL PELLETS;ORAL	20MG	0	OMEPRAZOLE	OMEPRAZOLE
003	CAPSULE, DELAYED REL PELLETS;ORAL	40MG	0	OMEPRAZOLE	OMEPRAZOLE

FDA Submissions

	ORIG	1	AP	2008-05-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-12-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-10-04
LABELING; Labeling	SUPPL	5	AP	2002-10-04
LABELING; Labeling	SUPPL	7	AP	2012-03-09
LABELING; Labeling	SUPPL	12	AP	2012-03-09
LABELING; Labeling	SUPPL	13	AP	2012-03-09
LABELING; Labeling	SUPPL	14	AP	2012-09-17	STANDARD
LABELING; Labeling	SUPPL	18	AP	2015-04-01	STANDARD
LABELING; Labeling	SUPPL	20	AP	2015-04-01	STANDARD
LABELING; Labeling	SUPPL	22	AP	2018-05-31	STANDARD
LABELING; Labeling	SUPPL	23	AP	2018-05-31	STANDARD
LABELING; Labeling	SUPPL	24	AP	2018-06-07	STANDARD
LABELING; Labeling	SUPPL	27	AP	2020-11-27	STANDARD
LABELING; Labeling	SUPPL	29	AP	2022-03-04	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	18	Null	15
SUPPL	20	Null	7
SUPPL	22	Null	7
SUPPL	23	Null	7
SUPPL	24	Null	15
SUPPL	27	Null	7
SUPPL	29	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75347
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"10MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"20MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"40MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OMEPRAZOLE","submission":"OMEPRAZOLE","actionType":"10MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OMEPRAZOLE","submission":"OMEPRAZOLE","actionType":"20MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OMEPRAZOLE","submission":"OMEPRAZOLE","actionType":"40MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)