FDA.reportPublic FDA data

Application 089886

Type
ANDA
Sponsor
HERCON PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROGLYCERINNITROGLYCERINFILM, EXTENDED RELEASE;TRANSDERMAL0.6MG/HRNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-5497Nitroglycerin Transdermal SystemNitroglycerinMajor PharmaceuticalsANDACurrent
0904-5497Nitroglycerin Transdermal SystemNitroglycerinMajor PharmaceuticalsANDACurrent
49730-113Nitroglycerin Transdermal SystemNitroglycerinHercon Laboratories CorporationANDACurrent
49730-113Nitroglycerin Transdermal SystemNitroglycerinHercon Laboratories CorporationANDACurrent
68382-311Nitroglycerin Transdermal SystemNitroglycerin Transdermal SystemZydus Pharmaceuticals USA Inc.ANDACurrent
68382-311Nitroglycerin Transdermal SystemNitroglycerin Transdermal SystemZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-311Nitroglycerin Transdermal SystemNitroglycerin Transdermal SystemZydus Pharmaceuticals (USA) Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18531ORIG2004-06-10
22705ORIG2003-07-30
31438ORIG1998-10-30