Home Applications 215574 Application 215574
Type ANDA
Sponsor HETERO LABS LTD V Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OSPEMIFENE OSPEMIFENE TABLET;ORAL 60MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215574-001 OSPEMIFENE OSPEMIFENE 60MG TABLET / ORAL 2024-02-13
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 2026-02-19 14:30 UTC 2026-02 A215574-001 OSPEMIFENE 60MG TABLET / ORAL 2024-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215574-001 OSPEMIFENE 60MG TABLET / ORAL 2024-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215574-001 OSPEMIFENE 60MG TABLET / ORAL 2024-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215574-001 OSPEMIFENE 60MG TABLET / ORAL AB 2024-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215574-001 OSPEMIFENE 60MG TABLET / ORAL AB 2024-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215574-001 OSPEMIFENE 60MG TABLET / ORAL AB 2024-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215574-001 OSPEMIFENE 60MG TABLET / ORAL AB 2024-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215574-001 OSPEMIFENE 60MG TABLET / ORAL AB 2024-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215574-001 OSPEMIFENE 60MG TABLET / ORAL AB 2024-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215574-001 OSPEMIFENE 60MG TABLET / ORAL AB 2024-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215574-001 OSPEMIFENE 60MG TABLET / ORAL AB 2024-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215574-001 OSPEMIFENE 60MG TABLET / ORAL AB 2024-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215574-001 OSPEMIFENE 60MG TABLET / ORAL AB 2024-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215574-001 OSPEMIFENE 60MG TABLET / ORAL AB 2024-02-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215574-001 OSPEMIFENE 60MG TABLET / ORAL AB 2024-02-13 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215574-001 OSPEMIFENE 60MG TABLET / ORAL 2024-02-13 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Osphena OSPEMIFENE Duchesnay USA, Inc. 9accbcc9-78ee-4f84-9b7e-704f2ab1c413 2025-02-14 Boxed warning, Warnings, Adverse reactions Name fallback generic name: OSPEMIFENE
Documents# Document, Submission type, Date table Document Submission type Date 74743 ORIG 2023-07-13