Home Applications 208247 Application 208247
Type ANDA
Sponsor STRIDES PHARMA 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 1 .
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 A208247-001 ROFLUMILAST ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 A208247-002 ROFLUMILAST ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20
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.
Product history page 1 of 2 · 58 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 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 1c564ffb4f44…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 58 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A208247-001 PC 2023-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208247-001 PC 2023-04-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208247-001 PC 2023-04-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208247-001 PC 2023-04-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208247-001 PC 2023-04-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208247-001 PC 2023-04-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208247-001 PC 2023-04-17 3bdfa0b2c4d7…
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 64380-786 roflumilast ROFLUMILAST Strides Pharma Science Limited ANDA Current 64380-786 roflumilast ROFLUMILAST Strides Pharma Science Limited ANDA Current