ANDA 076658

DR REDDYS LABS INC

FDA Drug Application

Application #076658

Documents

• Letter: 2004-07-30

Application Sponsors

ANDA 076658

DR REDDYS LABS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	50MG	0	FLUCONAZOLE	FLUCONAZOLE
002	TABLET;ORAL	100MG	0	FLUCONAZOLE	FLUCONAZOLE
003	TABLET;ORAL	150MG	0	FLUCONAZOLE	FLUCONAZOLE
004	TABLET;ORAL	200MG	0	FLUCONAZOLE	FLUCONAZOLE

FDA Submissions

	ORIG	1	AP	2004-07-29
LABELING; Labeling	SUPPL	4	AP	2015-03-14	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-03-14	STANDARD
LABELING; Labeling	SUPPL	9	AP	2015-03-14	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-07-16	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-07-16	STANDARD
LABELING; Labeling	SUPPL	16	AP	2019-07-16	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-07-16	STANDARD
LABELING; Labeling	SUPPL	19	AP	2022-07-06	STANDARD
LABELING; Labeling	SUPPL	20	AP	2022-07-06	STANDARD
LABELING; Labeling	SUPPL	21	AP	2022-07-06	STANDARD

Submissions Property Types

SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	9	Null	7
SUPPL	14	Null	7
SUPPL	15	Null	7
SUPPL	16	Null	15
SUPPL	17	Null	15
SUPPL	19	Null	7
SUPPL	20	Null	7
SUPPL	21	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76658
            [companyName] => DR REDDYS LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUCONAZOLE","activeIngredients":"FLUCONAZOLE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUCONAZOLE","activeIngredients":"FLUCONAZOLE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUCONAZOLE","activeIngredients":"FLUCONAZOLE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUCONAZOLE","activeIngredients":"FLUCONAZOLE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUCONAZOLE","submission":"FLUCONAZOLE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUCONAZOLE","submission":"FLUCONAZOLE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUCONAZOLE","submission":"FLUCONAZOLE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUCONAZOLE","submission":"FLUCONAZOLE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)