FDA.reportPublic FDA data

Application 075073

Type
ANDA
Sponsor
MYLAN TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROGLYCERINNITROGLYCERINFILM, EXTENDED RELEASE; TRANSDERMAL0.2MG/HRNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROLINGUALNITROGLYCERININDEPENDENCE PHARMACEUTICALS, LLCd19b5f51-ca85-48d6-9ccd-8ae26249cdc32024-05-13Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINCosette Pharmaceuticals, Inc.ac908e70-9425-4e9c-8c67-7b2882b402042024-02-21Warnings, Adverse reactionsName fallback
brand name: NITROGLYCERIN
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINProficient Rx LP160b85ac-d964-463b-9f1e-1429f14ed3182024-02-01Warnings, Adverse reactionsName fallback
brand name: NITROGLYCERIN
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINPrasco Laboratoriesf9731c86-34b0-42a2-8b39-eca907e02e742024-01-01Warnings, Adverse reactionsName fallback
brand name: Nitroglycerin
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINA-S Medication Solutionsfc297c0a-a412-40be-8414-4bf9906fd3002023-12-11Warnings, Adverse reactionsName fallback
brand name: Nitroglycerin
generic name: NITROGLYCERIN
GlonoinumNITROGLYCERINBoiron85a1163a-fe45-e31a-e053-2991aa0a64662023-11-13Name fallback
generic name: NITROGLYCERIN
GlonoinumNITROGLYCERINBoiron85a39d5c-2b11-62ed-e053-2a91aa0a0a312023-11-13Name fallback
generic name: NITROGLYCERIN
GlonoinumNITROGLYCERINBoiron85a33a5a-41c6-3d84-e053-2a91aa0a6ec72023-11-13Name fallback
generic name: NITROGLYCERIN
GlonoinumNITROGLYCERINBoiron7c0efc90-7a53-11e6-a302-424c583030312023-11-13Name fallback
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINAurobindo Pharma Limited26c314ea-077e-490b-826b-2aafcb6e95642023-11-01Warnings, Adverse reactionsName fallback
brand name: NITROGLYCERIN
generic name: NITROGLYCERIN
GlonoinumNITROGLYCERINBoiron85a47cfa-4d34-a596-e053-2a91aa0a02dc2023-10-30Name fallback
generic name: NITROGLYCERIN
GlonoinumNITROGLYCERINBoiron85a3b808-b45a-f2f0-e053-2a91aa0af21f2023-10-23Name fallback
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINNatco Pharma USA LLC941ac242-120e-47c1-ac03-50026ff93dd62023-07-20Warnings, Adverse reactionsName fallback
brand name: NITROGLYCERIN
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC6671d89f-cc89-c03c-e053-2a91aa0aa5fa2023-06-05Warnings, Adverse reactionsName fallback
brand name: Nitroglycerin
generic name: NITROGLYCERIN
NitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC8959095a-8cd8-f7d4-e053-2995a90a6e8f2023-05-31Warnings, Adverse reactionsName fallback
brand name: Nitroglycerin
generic name: NITROGLYCERIN
NITRO-DURNITROGLYCERINIngenus Pharmaceuticals, LLC5e15296c-5acd-4bcc-80a8-b49cb1ef3eb02023-05-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
NITROGLYCERINNITROGLYCERINMedical Purchasing Solutions, LLf9b52553-5a26-d374-e053-6294a90a40c72023-04-19Warnings, Adverse reactionsName fallback
brand name: NITROGLYCERIN
generic name: NITROGLYCERIN
GlonoinumNITROGLYCERINBoiron85a3f76b-7b09-5d00-e053-2a91aa0ad1de2023-02-20Name fallback
generic name: NITROGLYCERIN
NitrostatNITROGLYCERINViatris Specialty LLC9a52da75-d0af-4237-96c0-0b12adfa86362023-02-15Warnings, Adverse reactionsName fallback
generic name: NITROGLYCERIN
GlonoinumNITROGLYCERINBoiron85a39643-ae56-f21e-e053-2991aa0a49152023-01-23Name fallback
generic name: NITROGLYCERIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22412ORIG1999-11-12