FDA.reportPublic FDA data

Application 020145

Type
NDA
Sponsor
USPHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITRO-DURNITROGLYCERINFILM, EXTENDED RELEASE;TRANSDERMAL0.1MG/HRYesYes
002NITRO-DURNITROGLYCERINFILM, EXTENDED RELEASE;TRANSDERMAL0.2MG/HRYesYes
003NITRO-DURNITROGLYCERINFILM, EXTENDED RELEASE;TRANSDERMAL0.3MG/HRYesYes
004NITRO-DURNITROGLYCERINFILM, EXTENDED RELEASE;TRANSDERMAL0.4MG/HRYesYes
005NITRO-DURNITROGLYCERINFILM, EXTENDED RELEASE;TRANSDERMAL0.6MG/HRYesYes
006NITRO-DURNITROGLYCERINFILM, EXTENDED RELEASE;TRANSDERMAL0.8MG/HRYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-893Nitroglycerin Transdermal Infusion SystemNitroglycerinDr. Reddy's Laboratories, Inc.NDACurrent
43598-893Nitroglycerin Transdermal Infusion SystemNitroglycerinDr. Reddy's Laboratories, Inc.NDA AUTHORIZED GENERICCurrent
43598-894Nitroglycerin Transdermal Infusion SystemNitroglycerinDr. Reddy's Laboratories, Inc.NDA AUTHORIZED GENERICCurrent
43598-894Nitroglycerin Transdermal Infusion SystemNitroglycerinDr. Reddy's Laboratories, Inc.NDACurrent
43598-895Nitroglycerin Transdermal Infusion SystemNitroglycerinDr. Reddy's Laboratories, Inc.NDA AUTHORIZED GENERICCurrent
43598-895Nitroglycerin Transdermal Infusion SystemNitroglycerinDr. Reddy's Laboratories, Inc.NDACurrent
43598-896Nitroglycerin Transdermal Infusion SystemNitroglycerinDr. Reddy's Laboratories, Inc.NDA AUTHORIZED GENERICCurrent
43598-896Nitroglycerin Transdermal Infusion SystemNitroglycerinDr. Reddy's Laboratories, Inc.NDACurrent
50742-513NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-513NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-513NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-514NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-514NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-514NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-515NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-515NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-515NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-516NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-516NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-516NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-517NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-517NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-517NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-518NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-518NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent
50742-518NITRO-DURnitroglycerinIngenus Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
34297SUPPL2014-10-03
21207SUPPL2014-10-03
21206SUPPL2005-04-12
2064SUPPL2004-06-25
41155SUPPL2003-08-07
41154SUPPL2003-08-07
21205SUPPL2002-10-18