ANDA 074830

BAUSCH AND LOMB

FDA Drug Application

Application #074830

Documents

• Letter: 1999-01-25
• Review: 2003-04-30

Application Sponsors

ANDA 074830

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

0.01MG/SPRAY

0

DESMOPRESSIN ACETATE

DESMOPRESSIN ACETATE

FDA Submissions

	ORIG	1	AP	1999-01-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-04-28
LABELING; Labeling	SUPPL	4	AP	1999-10-25
LABELING; Labeling	SUPPL	8	AP	2004-09-21
LABELING; Labeling	SUPPL	13	AP	2008-04-25
LABELING; Labeling	SUPPL	15	AP	2015-04-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2015-01-14	UNKNOWN
LABELING; Labeling	SUPPL	22	AP	2021-08-18	STANDARD
LABELING; Labeling	SUPPL	23	AP	2021-08-18	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	15	Null	15
SUPPL	17	Null	15
SUPPL	22	Null	15
SUPPL	23	Null	15

TE Codes

001

Prescription

AB

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74830
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESMOPRESSIN ACETATE","activeIngredients":"DESMOPRESSIN ACETATE","strength":"0.01MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DESMOPRESSIN ACETATE","submission":"DESMOPRESSIN ACETATE","actionType":"0.01MG\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)