FDA.reportPublic FDA data

Application 089977

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THEOPHYLLINETHEOPHYLLINECAPSULE, EXTENDED RELEASE;ORAL200MGNoNo

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
A089977-001THEOPHYLLINETHEOPHYLLINE200MGCAPSULE, 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 22:54:322026-06A089977-001THEOPHYLLINE200MGCAPSULE, 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 1 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheophyllineTHEOPHYLLINEPD-Rx Pharmaceuticals, Inc.c6ca5cc9-4e5e-40cf-a36e-227aa4cb55c62026-07-29Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEPD-Rx Pharmaceuticals, Inc.5e64036a-ee3e-42e7-9e59-881f88a4e2982026-07-29Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
Theophylline (Anhydrous)THEOPHYLLINEGolden State Medical Supply, Inc.aa80b9f4-8a5d-3e14-e053-2a95a90a8aab2026-05-27Warnings, Adverse reactionsName fallback
generic name: THEOPHYLLINE
theophyllineTHEOPHYLLINEAmneal Pharmaceuticals NY LLCb0d5d1cd-c79b-4229-929c-2eb3e4f432982026-04-27Warnings, Adverse reactionsName fallback
brand name: theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEStrides Pharma Science Limitedb7a90ccf-9c32-40cc-9008-7e55b3da4dfd2026-03-10Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEChartwell RX, LLC1b685384-5d96-46fa-b93b-e96538a2cfe72026-02-06Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEGlenmark Pharmaceuticals Inc., USA48330a8e-be08-4d38-b8b1-d30fbd5a35de2026-01-29Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEGlenmark Pharmaceuticals Inc., USA56fc2167-ceb6-4e3e-8ff7-5e400dfbd5332026-01-29Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEAvKAREf93e20b1-97aa-088d-e053-6394a90a25d42026-01-19Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEChartwell RX, LLC9591d4db-2b88-4f0f-b61e-64ba67626e3d2025-12-10Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEATLANTIC BIOLOGICALS CORP.47e484c2-f59e-4a71-bb97-c90f128ac3452025-12-04Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEAjanta Pharma USA Inc.7a422c32-bbdf-4297-84f4-9c438c904b0c2025-11-30Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEChartwell Governmental & Specialty RX, LLC.e2716dac-8b23-4e06-bc3e-4dd76b7c813e2025-11-14Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEBryant Ranch Prepack62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd2025-10-22Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.701fbf9c-e06b-46f4-863b-981acf3021aa2025-07-10Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEBryant Ranch Prepack955dba5e-c3b7-4a45-8650-e1b4722dbaea2024-11-20Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
THEOPHYLLINETHEOPHYLLINEPAI Holdings, LLC dba PAI Pharma32b9780f-c46f-4e0f-9641-2cab60600e6e2024-11-19Warnings, Adverse reactionsName fallback
brand name: THEOPHYLLINE
generic name: THEOPHYLLINE
THEOPHYLLINETHEOPHYLLINELeading Pharma, LLCac490ebf-24e1-47c4-a932-ad4dcafe7aad2024-10-07Warnings, Adverse reactionsName fallback
brand name: THEOPHYLLINE
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINECranbury Pharmaceuticals, LLC78a99bfe-6ebe-4ace-80b0-ee019921435e2024-08-30Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE
TheophyllineTHEOPHYLLINEViona Pharmaceuticals Incabdfb9b9-9402-4761-9347-8eb1c4d862422024-05-22Warnings, Adverse reactionsName fallback
brand name: Theophylline
generic name: THEOPHYLLINE