FDA.reportPublic FDA data

Application 089885

Type
ANDA
Sponsor
HERCON PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROGLYCERINNITROGLYCERINFILM, EXTENDED RELEASE;TRANSDERMAL0.4MG/HRNoNo
002NITROGLYCERINNITROGLYCERINFILM, EXTENDED RELEASE;TRANSDERMAL0.1MG/HRNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-5496Nitroglycerin Transdermal SystemnitroglycerinMajor PharmaceuticalsANDACurrent
0904-5496Nitroglycerin Transdermal SystemnitroglycerinMajor PharmaceuticalsANDACurrent
0904-5496Nitroglycerin Transdermal SystemnitroglycerinMajor PharmaceuticalsANDACurrent
49730-112Nitroglycerin Transdermal SystemNitroglycerinHercon Laboratories CorporationANDACurrent
68382-310Nitroglycerin Transdermal SystemNitroglycerin Transdermal SystemZydus Pharmaceuticals USA Inc.ANDACurrent
68382-310Nitroglycerin Transdermal SystemNitroglycerin Transdermal SystemZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-310Nitroglycerin Transdermal SystemNitroglycerin Transdermal SystemZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1477Nitroglycerin Transdermal SystemNitroglycerin Transdermal SystemZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1477Nitroglycerin Transdermal SystemNitroglycerin Transdermal SystemZydus Pharmaceuticals USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18530ORIG2004-06-10
22704ORIG2003-07-30
9249ORIG1998-10-30