FDA.reportPublic FDA data

Application 089976

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THEOPHYLLINETHEOPHYLLINECAPSULE, EXTENDED RELEASE;ORAL100MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089976-001THEOPHYLLINETHEOPHYLLINE100MGCAPSULE, EXTENDED RELEASE / ORAL1995-01-04

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 22:54:322026-06A089976-001THEOPHYLLINE100MGCAPSULE, EXTENDED RELEASE / ORAL1995-01-04a50c72e98297…

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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheophyllineTHEOPHYLLINEZydus Lifesciences Limited7339f98d-b996-4e20-a7a7-315fd2a9fa4d2024-05-22Name fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEHarman Finochem Limited098db8bb-fa9a-4577-b7d9-86caaefc168a2024-04-27Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEBionpharma Inc.,63517422-45a0-4e78-8505-eca054068ee92023-10-12Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINECamber Pharmaceuticals, Inc.bf320619-c53b-49a7-97b5-cd0c075a9f752023-09-20Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEAlembic Pharmaceuticals Limited31f3c720-1597-4d43-9296-33017b90b15f2023-01-11Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINETeva Pharmaceuticals, Inc.25eabefa-518b-4030-9b72-01ac8b3deba92022-04-01Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEAlembic Pharmaceuticals Inc.77e849b8-900b-4f0d-ac5c-1391abcd57212021-10-01Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE