ANDA 075658

SPECGX LLC

FDA Drug Application

Application #075658

Documents

• Other Important Information from FDA: 2005-08-01
• Letter: 2004-06-04

Application Sponsors

ANDA 075658

SPECGX LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	EQ 10MG BASE	0	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 20MG BASE	0	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-01-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-11-05
LABELING; Labeling	SUPPL	3	AP	2002-11-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-11-05
LABELING; Labeling	SUPPL	6	AP	2002-11-24
LABELING; Labeling	SUPPL	7	AP	2003-11-13
LABELING; Labeling	SUPPL	11	AP	2004-08-20
LABELING; Labeling	SUPPL	13	AP	2004-12-06
LABELING; Labeling	SUPPL	16	AP	2004-12-06
LABELING; Labeling	SUPPL	19	AP	2005-10-21
LABELING; Labeling	SUPPL	20	AP	2006-02-28
LABELING; Labeling	SUPPL	21	AP	2006-02-28
LABELING; Labeling	SUPPL	22	AP	2006-09-27
LABELING; Labeling	SUPPL	23	AP	2007-06-29
LABELING; Labeling	SUPPL	25	AP	2007-06-29
LABELING; Labeling	SUPPL	26	AP	2008-03-03
LABELING; Labeling	SUPPL	27	AP	2008-09-25
LABELING; Labeling	SUPPL	28	AP	2009-09-28
LABELING; Labeling	SUPPL	29	AP	2017-07-12	STANDARD
LABELING; Labeling	SUPPL	30	AP	2020-07-20	STANDARD
LABELING; Labeling	SUPPL	31	AP	2020-07-20	STANDARD
LABELING; Labeling	SUPPL	32	AP	2020-07-20	STANDARD
LABELING; Labeling	SUPPL	33	AP	2020-07-20	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	28	Null	7
SUPPL	29	Null	15
SUPPL	30	Null	7
SUPPL	31	Null	7
SUPPL	32	Null	7
SUPPL	33	Null	15

TE Codes

001	Prescription	AB1
002	Prescription	AB1

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75658
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)