FDA.reportPublic FDA data

Application 018705

Type
NDA
Sponsor
POHL BOSKAMP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROLINGUALNITROGLYCERINAEROSOL;SUBLINGUAL0.4MG/SPRAYNoNo
002NITROLINGUAL PUMPSPRAYNITROGLYCERINSPRAY, METERED;SUBLINGUAL0.4MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
28595-120NITROGLYCERIN LINGUALNitroglycerinAllegis Pharmaceuticals, LLCNDACurrent
28595-550NITROLINGUALNitroglycerinAllegis Pharmaceuticals, LLCNDACurrent
51662-1244NITROGLYCERINNITROGLYCERINHF Acquisition Co. LLC, DBA Health FirstNDACurrent
51662-1244NITROGLYCERINNITROGLYCERINHF Acquisition Co. LLC, DBA Health FirstNDACurrent
51662-1244NITROGLYCERINNITROGLYCERINHF Acquisition Co. LLC, DBA Health FirstNDACurrent
51662-1244NITROGLYCERINNITROGLYCERINHF Acquisition Co. LLC, DBA Health FirstNDACurrent
51662-1351NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1351NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1351NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1351NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1519NITROGLYCERIN LINGUALNITROGLYCERIN LINGUALHF Acquisition Co LLC, DBA HealthFirstNDACurrent
70003-300NITROGLYCERIN LINGUALNitroglycerinJacksonville Pharmaceuticals, Inc.NDACurrent
70003-300NITROGLYCERIN LINGUALNitroglycerinJacksonville Pharmaceuticals, Inc.NDACurrent
70007-300NITROLINGUALNitroglycerinEspero Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55078SUPPL2018-08-02
55058SUPPL2018-07-30
33566SUPPL2015-01-30
15106SUPPL2015-01-26
11288SUPPL2008-10-09
15105SUPPL2008-10-06
1041SUPPL2006-10-02
1040SUPPL2006-02-22
1039SUPPL2004-09-03
1038SUPPL2002-11-05