NDA 016419

BAXTER HLTHCARE CORP

FDA Drug Application

Application #016419

Documents

• Letter: 2006-07-27
• Label: 2015-04-16
• Letter: 2008-04-09

Application Sponsors

NDA 016419

BAXTER HLTHCARE CORP

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

1

PROPRANOLOL HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1967-11-13	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1978-08-21
LABELING; Labeling	SUPPL	12	AP	1979-01-17
LABELING; Labeling	SUPPL	13	AP	1978-12-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1981-03-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1982-06-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1982-06-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1985-06-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1988-08-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1988-12-06	PRIORITY
LABELING; Labeling	SUPPL	20	AP	1990-02-14
LABELING; Labeling	SUPPL	21	AP	1997-11-07	STANDARD
LABELING; Labeling	SUPPL	22	AP	1999-08-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2001-02-14	PRIORITY
LABELING; Labeling	SUPPL	24	AP	2002-02-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2001-12-07	PRIORITY
LABELING; Labeling	SUPPL	26	AP	2006-07-24	STANDARD
LABELING; Labeling	SUPPL	29	AP	2008-04-01	STANDARD

Submissions Property Types

SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16419
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPRANOLOL HYDROCHLORIDE","activeIngredients":"PROPRANOLOL HYDROCHLORIDE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/01\/2008","submission":"SUPPL-29","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/016419s029lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PROPRANOLOL HYDROCHLORIDE","submission":"PROPRANOLOL HYDROCHLORIDE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2008-04-01
        )

)