FDA.reportPublic FDA data

Application 216890

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIAZOLAMTRIAZOLAMTABLET;ORAL0.125MGNoNo
002TRIAZOLAMTRIAZOLAMTABLET;ORAL0.25MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216890-001TRIAZOLAMTRIAZOLAM0.125MGTABLET / ORAL2022-11-08
A216890-002TRIAZOLAMTRIAZOLAM0.25MGTABLET / ORAL2022-11-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A216890-001TRIAZOLAM0.125MGTABLET / ORAL2022-11-08a50c72e98297…
2026-08-01 22:54:322026-06A216890-002TRIAZOLAM0.25MGTABLET / ORAL2022-11-08a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TriazolamTRIAZOLAMMylan Pharmaceuticals Inc.5add318e-11b9-42f8-b052-0d8cebb32fcf2026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triazolam
generic name: TRIAZOLAM
TriazolamTRIAZOLAMProficient Rx LPba1d8955-41f8-4b4d-8ed8-e92667e294a12026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triazolam
generic name: TRIAZOLAM
TriazolamTRIAZOLAMA-S Medication Solutions0a96c618-1869-4cb6-b9f3-549e8581af722025-11-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triazolam
generic name: TRIAZOLAM
TriazolamTRIAZOLAMPD-Rx Pharmaceuticals, Inc.f8ca4773-e201-4cb9-8869-5ee07ba1d0bf2025-10-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triazolam
generic name: TRIAZOLAM
TriazolamTRIAZOLAMBryant Ranch Prepack5fccc31d-32c9-49e7-91a9-664cc726872b2024-08-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triazolam
generic name: TRIAZOLAM
TriazolamTRIAZOLAMZydus Lifesciences Limited4084da13-5825-4399-ad69-de701508c71d2024-08-14Name fallback
brand name: Triazolam
generic name: TRIAZOLAM
TriazolamTRIAZOLAMA-S Medication Solutions5a330f08-5d8f-4f8d-8847-a45b734412b42023-05-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triazolam
generic name: TRIAZOLAM
TriazolamTRIAZOLAMZydus Pharmaceuticals USA Inc.8d414eb8-eec9-486f-90fc-00eed0cf7daf2023-02-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triazolam
generic name: TRIAZOLAM
TriazolamTRIAZOLAMIngenus Pharmaceuticals, LLCa0c99f0b-4122-4611-9b53-80fadfceacb62023-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triazolam
generic name: TRIAZOLAM
TriazolamTRIAZOLAMAphena Pharma Solutions - Tennessee, LLC97164a9c-4bc7-4f15-829e-5f9e653c7fa52017-11-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Triazolam
generic name: TRIAZOLAM