Home Applications 079050 Application 079050
Type ANDA
Sponsor CELLTRION Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.25MG BASE No No 002 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.5MG BASE No No 003 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE No No 004 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE No No 005 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 3MG BASE No No 006 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE No No 007 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079050-001 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2008-05-29 A079050-002 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2008-05-29 A079050-003 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-05-29 A079050-004 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2008-05-29 A079050-005 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2008-05-29 A079050-006 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2008-05-29 A079050-007 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-05-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 matching rows.
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 8 · 287 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A079050-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2008-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079050-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2008-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079050-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079050-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2008-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079050-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2008-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079050-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2008-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079050-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079050-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2008-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079050-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2008-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079050-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079050-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2008-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079050-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2008-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079050-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2008-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079050-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079050-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2008-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079050-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2008-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079050-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079050-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2008-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079050-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2008-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079050-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2008-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079050-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079050-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2008-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079050-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2008-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079050-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079050-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2008-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079050-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2008-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079050-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2008-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079050-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079050-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2008-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079050-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2008-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079050-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079050-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2008-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079050-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2008-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079050-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2008-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079050-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-05-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079050-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2008-05-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079050-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2008-05-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079050-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-05-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079050-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2008-05-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079050-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2008-05-29 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 8 · 287 observed states.
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ropinirole hydrochloride ROPINIROLE HYDROCHLORIDE A-S Medication Solutions a97d5e2d-4a17-4d80-9216-1b0780199502 2026-03-23 Warnings, Adverse reactions Name fallback brand name: ropinirole hydrochloride generic name: ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride ROPINIROLE HYDROCHLORIDE Northwind Health Company, LLC ab6d21b6-2584-4b97-e053-2a95a90adc50 2026-01-01 Warnings, Adverse reactions Name fallback brand name: ropinirole hydrochloride generic name: ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride ROPINIROLE HYDROCHLORIDE SOLCO HEALTHCARE US, LLC 7734ef0b-584f-42dd-a8b5-adbdf4e4df93 2025-05-30 Warnings, Adverse reactions Name fallback brand name: ropinirole hydrochloride generic name: ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride ROPINIROLE HYDROCHLORIDE SOLCO HEALTHCARE US, LLC 5823b3a2-3256-4d94-97b4-ec6b940312f4 2025-05-28 Warnings, Adverse reactions Name fallback brand name: ropinirole hydrochloride generic name: ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE Bryant Ranch Prepack 3b8bb729-e084-4d45-9774-63cae192be32 2025-01-29 Warnings, Adverse reactions Name fallback brand name: ROPINIROLE HYDROCHLORIDE generic name: ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE AvKARE abd344d9-7635-62a2-d4e1-38fc46937397 2025-01-09 Warnings, Adverse reactions Name fallback brand name: ROPINIROLE HYDROCHLORIDE generic name: ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride ROPINIROLE HYDROCHLORIDE AvPAK e699a31a-25fc-554b-e053-2a95a90a843a 2025-01-09 Warnings, Adverse reactions Name fallback brand name: ropinirole hydrochloride generic name: ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride ROPINIROLE HYDROCHLORIDE American Health Packaging 6849b3c0-e36b-4bea-82f2-b33ae3d44c95 2025-01-08 Warnings, Adverse reactions Name fallback brand name: ropinirole hydrochloride generic name: ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE NCS HealthCare of KY, LLC dba Vangard Labs 48a63d7e-c0af-4b09-863c-2af7beb2e80f 2024-10-24 Warnings, Adverse reactions Name fallback brand name: ROPINIROLE HYDROCHLORIDE generic name: ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE Bryant Ranch Prepack 00c0ab77-914a-4e8a-bcb7-24cecacfebb1 2024-10-07 Warnings, Adverse reactions Name fallback brand name: ROPINIROLE HYDROCHLORIDE generic name: ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride ROPINIROLE HYDROCHLORIDE Bryant Ranch Prepack 6c10444a-48da-469d-bf8f-1e6e0b7e15f8 2023-10-30 Warnings, Adverse reactions Name fallback brand name: ropinirole hydrochloride generic name: ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride ROPINIROLE HYDROCHLORIDE Proficient Rx LP 89e3865c-1fe1-4f29-9606-8830df4bbe53 2023-08-01 Warnings, Adverse reactions Name fallback brand name: ropinirole hydrochloride generic name: ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride ROPINIROLE HYDROCHLORIDE A-S Medication Solutions 9c4dacc6-cebc-4f42-85fc-41083512b290 2023-03-01 Warnings, Adverse reactions Name fallback brand name: ropinirole hydrochloride generic name: ROPINIROLE HYDROCHLORIDE
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55648-154 Ropinirole Hydrochloride Ropinirole Hydrochloride Wockhardt Limited ANDA Current 55648-155 Ropinirole Hydrochloride Ropinirole Hydrochloride Wockhardt Limited ANDA Current 55648-171 Ropinirole Hydrochloride Ropinirole Hydrochloride Wockhardt Limited ANDA Current 55648-172 Ropinirole Hydrochloride Ropinirole Hydrochloride Wockhardt Limited ANDA Current 55648-174 Ropinirole Hydrochloride Ropinirole Hydrochloride Wockhardt Limited ANDA Current 55648-175 Ropinirole Hydrochloride Ropinirole Hydrochloride Wockhardt Limited ANDA Current 55648-177 Ropinirole Hydrochloride Ropinirole Hydrochloride Wockhardt Limited ANDA Current 64679-154 ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride Wockhardt USA LLC. ANDA Current 64679-155 ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride Wockhardt USA LLC. ANDA Current 64679-171 ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride Wockhardt USA LLC. ANDA Current 64679-172 ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride Wockhardt USA LLC. ANDA Current 64679-174 ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride Wockhardt USA LLC. ANDA Current 64679-175 ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride Wockhardt USA LLC. ANDA Current 64679-177 ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride Wockhardt USA LLC. ANDA Current