FDA.reportPublic FDA data

Application 078230

Type
ANDA
Sponsor
EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET;ORALEQ 0.25MG BASENoNo
002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET;ORALEQ 0.5MG BASENoNo
003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET;ORALEQ 1MG BASENoNo
004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET;ORALEQ 2MG BASENoNo
005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET;ORALEQ 3MG BASENoNo
006ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET;ORALEQ 4MG BASENoNo
007ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET;ORALEQ 5MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078230-001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORAL2008-05-20
A078230-002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2008-05-20
A078230-003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2008-05-20
A078230-004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORAL2008-05-20
A078230-005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORAL2008-05-20
A078230-006ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2008-05-20
A078230-007ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2008-05-20

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 22:54:322026-06A078230-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORAL2008-05-20a50c72e98297…
2026-08-01 22:54:322026-06A078230-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2008-05-20a50c72e98297…
2026-08-01 22:54:322026-06A078230-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2008-05-20a50c72e98297…
2026-08-01 22:54:322026-06A078230-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORAL2008-05-20a50c72e98297…
2026-08-01 22:54:322026-06A078230-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORAL2008-05-20a50c72e98297…
2026-08-01 22:54:322026-06A078230-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2008-05-20a50c72e98297…
2026-08-01 22:54:322026-06A078230-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2008-05-20a50c72e98297…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEA-S Medication Solutionsa97d5e2d-4a17-4d80-9216-1b07801995022026-03-23Warnings, Adverse reactionsName fallback
brand name: ropinirole hydrochloride
generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDENorthwind Health Company, LLCab6d21b6-2584-4b97-e053-2a95a90adc502026-01-01Warnings, Adverse reactionsName fallback
brand name: ropinirole hydrochloride
generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDESOLCO HEALTHCARE US, LLC7734ef0b-584f-42dd-a8b5-adbdf4e4df932025-05-30Warnings, Adverse reactionsName fallback
brand name: ropinirole hydrochloride
generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDESOLCO HEALTHCARE US, LLC5823b3a2-3256-4d94-97b4-ec6b940312f42025-05-28Warnings, Adverse reactionsName fallback
brand name: ropinirole hydrochloride
generic name: ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEBryant Ranch Prepack3b8bb729-e084-4d45-9774-63cae192be322025-01-29Warnings, Adverse reactionsName fallback
brand name: ROPINIROLE HYDROCHLORIDE
generic name: ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEAvKAREabd344d9-7635-62a2-d4e1-38fc469373972025-01-09Warnings, Adverse reactionsName fallback
brand name: ROPINIROLE HYDROCHLORIDE
generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEAvPAKe699a31a-25fc-554b-e053-2a95a90a843a2025-01-09Warnings, Adverse reactionsName fallback
brand name: ropinirole hydrochloride
generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEAmerican Health Packaging6849b3c0-e36b-4bea-82f2-b33ae3d44c952025-01-08Warnings, Adverse reactionsName fallback
brand name: ropinirole hydrochloride
generic name: ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs48a63d7e-c0af-4b09-863c-2af7beb2e80f2024-10-24Warnings, Adverse reactionsName fallback
brand name: ROPINIROLE HYDROCHLORIDE
generic name: ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEBryant Ranch Prepack00c0ab77-914a-4e8a-bcb7-24cecacfebb12024-10-07Warnings, Adverse reactionsName fallback
brand name: ROPINIROLE HYDROCHLORIDE
generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEBryant Ranch Prepack6c10444a-48da-469d-bf8f-1e6e0b7e15f82023-10-30Warnings, Adverse reactionsName fallback
brand name: ropinirole hydrochloride
generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEProficient Rx LP89e3865c-1fe1-4f29-9606-8830df4bbe532023-08-01Warnings, Adverse reactionsName fallback
brand name: ropinirole hydrochloride
generic name: ROPINIROLE HYDROCHLORIDE
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEA-S Medication Solutions9c4dacc6-cebc-4f42-85fc-41083512b2902023-03-01Warnings, Adverse reactionsName fallback
brand name: ropinirole hydrochloride
generic name: ROPINIROLE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-792ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDERebel Distributors CorpANDACurrent
21695-794ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDERebel Distributors CorpANDACurrent
21695-798ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDERebel Distributors CorpANDACurrent