Home Applications 213298 Application 213298
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ROFLUMILAST ROFLUMILAST TABLET;ORAL 500MCG No No 002 ROFLUMILAST ROFLUMILAST TABLET;ORAL 250MCG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213298-001 ROFLUMILAST ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 A213298-002 ROFLUMILAST ROFLUMILAST 250MCG TABLET / ORAL AB 2025-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
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 2026-08-18 06:07:40 2026-07 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213298-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2025-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213298-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2025-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213298-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2025-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213298-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2025-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213298-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2025-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213298-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2025-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213298-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2025-01-31 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Documents# Document, Submission type, Date table Document Submission type Date 72945 ORIG 2022-12-20