Home Applications 208743 Application 208743
Type NDA
Sponsor RADIUS HEALTH INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TYMLOS ABALOPARATIDE SOLUTION;SUBCUTANEOUS 3.12MG/1.56ML (2MG/ML) Yes Yes
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 N208743-001 TYMLOS ABALOPARATIDE 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208743-001 8748382 2027-10-03 U-2009 2017-05-25 N208743-001 8748382 2027-10-03 U-3543 2017-05-25 N208743-001 8148333 2027-11-08 Drug product 2017-05-25 N208743-001 7803770 2031-04-28 U-2009 2017-05-25 N208743-001 RE49444 2031-04-28 U-2009 2023-03-14 N208743-001 RE49444 2031-04-28 U-3543 2023-03-14 N208743-001 10996208 2038-04-30 Drug product 2021-06-01 N208743-001 11782041 2038-04-30 U-2009 Drug product 2023-10-23 N208743-001 11782041 2038-04-30 U-3543 Drug product 2023-10-23 N208743-001 11977067 2038-04-30 Drug product 2024-05-16 N208743-001 11255842 2040-01-10 U-3322 2022-03-14 N208743-001 11680942 2040-01-10 U-3322 2023-07-20
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 · 41 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 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 9 · 327 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208743-001 8748382 2027-10-03 U-3543 2017-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 8748382 2027-10-03 U-2009 2017-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 8148333 2027-11-08 Drug product 2017-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 7803770 2031-04-28 U-2009 2017-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 RE49444 2031-04-28 U-2009 2023-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 RE49444 2031-04-28 U-3543 2023-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 10996208 2038-04-30 Drug product 2021-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 11782041 2038-04-30 U-2009 Drug product 2023-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 11782041 2038-04-30 U-3543 Drug product 2023-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 11977067 2038-04-30 Drug product 2024-05-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 11255842 2040-01-10 U-3322 2022-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 11680942 2040-01-10 U-3322 2023-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 8748382 2027-10-03 U-3543 2017-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 8748382 2027-10-03 U-2009 2017-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 8148333 2027-11-08 Drug product 2017-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 7803770 2031-04-28 U-2009 2017-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 RE49444 2031-04-28 U-2009 2023-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 RE49444 2031-04-28 U-3543 2023-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 10996208 2038-04-30 Drug product 2021-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 11782041 2038-04-30 U-2009 Drug product 2023-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 11782041 2038-04-30 U-3543 Drug product 2023-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 11977067 2038-04-30 Drug product 2024-05-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 11255842 2040-01-10 U-3322 2022-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 11680942 2040-01-10 U-3322 2023-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208743-001 8748382 2027-10-03 U-3543 2017-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 8748382 2027-10-03 U-2009 2017-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 8148333 2027-11-08 Drug product 2017-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 7803770 2031-04-28 U-2009 2017-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 RE49444 2031-04-28 U-2009 2023-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 RE49444 2031-04-28 U-3543 2023-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 10996208 2038-04-30 Drug product 2021-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 11782041 2038-04-30 U-2009 Drug product 2023-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 11782041 2038-04-30 U-3543 Drug product 2023-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 11977067 2038-04-30 Drug product 2024-05-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 11255842 2040-01-10 U-3322 2022-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 11680942 2040-01-10 U-3322 2023-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208743-001 8748382 2027-10-03 U-3543 2017-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208743-001 8748382 2027-10-03 U-2009 2017-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208743-001 8148333 2027-11-08 Drug product 2017-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208743-001 7803770 2031-04-28 U-2009 2017-05-25 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 65 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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70539-001 Tymlos abaloparatide Radius Health, Inc. NDA Current 70539-001 Tymlos abaloparatide Radius Health, Inc. NDA Current 70539-001 Tymlos abaloparatide Radius Health, Inc. NDA Current 70539-001 Tymlos abaloparatide Radius Health, Inc. NDA Current 70539-001 Tymlos abaloparatide Radius Health, Inc. NDA Current 70539-001 Tymlos abaloparatide Radius Health, Inc. NDA Current 70539-001 Tymlos abaloparatide Radius Health, Inc. NDA Current 70539-001 Tymlos abaloparatide Radius Health, Inc. NDA Current