Application 091395

Type
ANDA
Sponsor
CELLTRION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 2MG BASENoNo
002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 4MG BASENoNo
003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 6MG BASENoNo
004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 8MG BASENoNo
005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 12MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091395-001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27
A091395-002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27
A091395-003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27
A091395-004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27
A091395-005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A091395-001AB
A091395-002AB
A091395-003AB
A091395-004AB
A091395-005AB

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.

Product history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091395-001ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091395-002ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091395-003ROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091395-004ROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091395-005ROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091395-001ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091395-002ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091395-003ROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091395-004ROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091395-005ROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A091395-001ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091395-002ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091395-003ROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091395-004ROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091395-005ROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091395-001ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091395-002ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091395-003ROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091395-004ROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091395-005ROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091395-001ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091395-002ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091395-003ROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091395-004ROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091395-005ROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091395-001ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091395-002ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091395-003ROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091395-004ROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091395-005ROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091395-001ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091395-002ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091395-003ROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091395-004ROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091395-005ROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091395-001ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091395-002ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091395-003ROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091395-004ROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091395-005ROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2012-08-275bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091395-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091395-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091395-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091395-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091395-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091395-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091395-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091395-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091395-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091395-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091395-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091395-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091395-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091395-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091395-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091395-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091395-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091395-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091395-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091395-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091395-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091395-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091395-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091395-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091395-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091395-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091395-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091395-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091395-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091395-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091395-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091395-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091395-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091395-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091395-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091395-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091395-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091395-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091395-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091395-005AB15bbf6a4d5a75…

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 · 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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55648-771Ropinirole HydrochlorideRopinirole HydrochlorideWockhardt LimitedANDACurrent
55648-773Ropinirole HydrochlorideRopinirole HydrochlorideWockhardt LimitedANDACurrent
55648-774Ropinirole HydrochlorideRopinirole HydrochlorideWockhardt LimitedANDACurrent
55648-775Ropinirole HydrochlorideRopinirole HydrochlorideWockhardt LimitedANDACurrent
55648-776Ropinirole HydrochlorideRopinirole HydrochlorideWockhardt LimitedANDACurrent
64679-771Ropinirole HydrochlorideRopinirole HydrochlorideWockhardt USA LLC.ANDACurrent
64679-773Ropinirole HydrochlorideRopinirole HydrochlorideWockhardt USA LLC.ANDACurrent
64679-774Ropinirole HydrochlorideRopinirole HydrochlorideWockhardt USA LLC.ANDACurrent
64679-775Ropinirole HydrochlorideRopinirole HydrochlorideWockhardt USA LLC.ANDACurrent
64679-776Ropinirole HydrochlorideRopinirole HydrochlorideWockhardt USA LLC.ANDACurrent