ANDA 062421

ACTAVIS LABS FL INC

FDA Drug Application

Application #062421

Application Sponsors

ANDA 062421

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 100MG BASE

0

DOXYCYCLINE HYCLATE

DOXYCYCLINE HYCLATE

FDA Submissions

	ORIG	1	AP	1983-02-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1988-09-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1988-10-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1990-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1991-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1990-11-15
LABELING; Labeling	SUPPL	18	AP	1992-02-26
LABELING; Labeling	SUPPL	19	AP	1992-10-23
LABELING; Labeling	SUPPL	20	AP	1993-04-14
LABELING; Labeling	SUPPL	21	AP	1993-09-01
LABELING; Labeling	SUPPL	23	AP	2000-08-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2000-12-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2001-05-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2001-04-25
LABELING; Labeling	SUPPL	27	AP	2003-04-18
LABELING; Labeling	SUPPL	28	AP	2002-12-23
LABELING; Labeling	SUPPL	32	AP	2005-09-01
LABELING; Labeling	SUPPL	52	AP	2010-07-28
LABELING; Labeling	SUPPL	60	AP	2012-12-14	STANDARD
LABELING; Labeling	SUPPL	62	AP	2018-01-02	STANDARD
LABELING; Labeling	SUPPL	67	AP	2018-01-02	STANDARD
LABELING; Labeling	SUPPL	68	AP	2018-01-02	STANDARD
LABELING; Labeling	SUPPL	69	AP	2021-05-17	STANDARD
LABELING; Labeling	SUPPL	70	AP	2021-05-17	STANDARD

Submissions Property Types

SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	60	Null	15
SUPPL	62	Null	15
SUPPL	67	Null	15
SUPPL	68	Null	7
SUPPL	69	Null	7
SUPPL	70	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62421
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOXYCYCLINE HYCLATE","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)