FDA.reportPublic FDA data

Application 021681

Type
NDA
Sponsor
MISSION PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TINDAMAXTINIDAZOLETABLET; ORAL250MGNoNo
002TINDAMAXTINIDAZOLETABLET; ORAL500MGNoNo

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 1 of 1 ยท 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TinidazoleTINIDAZOLEEdenbridge Pharmaceuticals LLC.6f3ce597-64c1-4204-a67a-8b6f6e7e8bca2025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TINIDAZOLE
TinidazoleTINIDAZOLEBioComp Pharma, Inc.f55bcc41-2e8d-4ee5-9993-05c7d86f2d2c2025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TINIDAZOLE
TindazoleTINIDAZOLERising Pharma Holdings, Inc.32167dd7-5d37-457b-9b00-cd735de6b0602025-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TINIDAZOLE
TinidazoleTINIDAZOLEChartwell RX, LLCb39bc167-f1c4-4169-8b46-e6c2eafe6bbf2024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TINIDAZOLE
TinidazoleTINIDAZOLELupin Pharmaceuticals,Inc.95ab57b2-5d7e-4986-abcd-65edf17283832022-02-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TINIDAZOLE
TindamaxTINIDAZOLEMission Pharmacal Companya0d01539-8413-4703-94cc-d221918630a12021-12-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tindamax
generic name: TINIDAZOLE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
21777ORIG2005-02-02