ANDA 062031

ACTAVIS LABS FL INC

FDA Drug Application

Application #062031

Application Sponsors

ANDA 062031

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	EQ 100MG BASE	0	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE
002	CAPSULE;ORAL	EQ 50MG BASE	0	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE

FDA Submissions

	ORIG	1	AP	1982-10-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1988-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1991-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1990-11-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1991-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1990-11-15
LABELING; Labeling	SUPPL	25	AP	1992-02-26
LABELING; Labeling	SUPPL	26	AP	1992-10-23
LABELING; Labeling	SUPPL	27	AP	1993-04-14
LABELING; Labeling	SUPPL	28	AP	1993-09-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1998-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1998-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1998-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1998-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1999-06-16
LABELING; Labeling	SUPPL	35	AP	2000-08-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2001-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2001-04-25
LABELING; Labeling	SUPPL	38	AP	2002-02-20
LABELING; Labeling	SUPPL	39	AP	2002-12-23
LABELING; Labeling	SUPPL	43	AP	2005-09-01
LABELING; Labeling	SUPPL	63	AP	2010-07-28
LABELING; Labeling	SUPPL	74	AP	2014-04-30	STANDARD
LABELING; Labeling	SUPPL	79	AP	2018-01-02	STANDARD
LABELING; Labeling	SUPPL	80	AP	2018-01-02	STANDARD
LABELING; Labeling	SUPPL	81	AP	2021-05-17	STANDARD
LABELING; Labeling	SUPPL	82	AP	2021-05-17	STANDARD

Submissions Property Types

SUPPL	16	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	34	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	74	Null	15
SUPPL	79	Null	7
SUPPL	80	Null	15
SUPPL	81	Null	15
SUPPL	82	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62031
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOXYCYCLINE HYCLATE","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 100MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXYCYCLINE HYCLATE","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 50MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)