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 44.

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208743-001	TYMLOS	3.12MG/1.56ML (2MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2017-04-28	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 363 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N208743-001	8748382	2027-10-03	U-3543		2017-05-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208743-001	8748382	2027-10-03	U-2009		2017-05-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208743-001	8148333	2027-11-08		Drug product	2017-05-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208743-001	7803770	2031-04-28	U-2009		2017-05-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208743-001	RE49444	2031-04-28	U-2009		2023-03-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208743-001	RE49444	2031-04-28	U-3543		2023-03-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208743-001	10996208	2038-04-30		Drug product	2021-06-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208743-001	11782041	2038-04-30	U-2009	Drug product	2023-10-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208743-001	11782041	2038-04-30	U-3543	Drug product	2023-10-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208743-001	11977067	2038-04-30		Drug product	2024-05-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208743-001	11255842	2040-01-10	U-3322		2022-03-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208743-001	11680942	2040-01-10	U-3322		2023-07-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208743-001	8748382	2027-10-03	U-3543		2017-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208743-001	8748382	2027-10-03	U-2009		2017-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208743-001	8148333	2027-11-08		Drug product	2017-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208743-001	7803770	2031-04-28	U-2009		2017-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208743-001	RE49444	2031-04-28	U-2009		2023-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208743-001	RE49444	2031-04-28	U-3543		2023-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208743-001	10996208	2038-04-30		Drug product	2021-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208743-001	11782041	2038-04-30	U-2009	Drug product	2023-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208743-001	11782041	2038-04-30	U-3543	Drug product	2023-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208743-001	11977067	2038-04-30		Drug product	2024-05-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208743-001	11255842	2040-01-10	U-3322		2022-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208743-001	11680942	2040-01-10	U-3322		2023-07-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208743-001	8748382	2027-10-03	U-3543		2017-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208743-001	8748382	2027-10-03	U-2009		2017-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208743-001	8148333	2027-11-08		Drug product	2017-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208743-001	7803770	2031-04-28	U-2009		2017-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208743-001	RE49444	2031-04-28	U-2009		2023-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208743-001	RE49444	2031-04-28	U-3543		2023-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208743-001	10996208	2038-04-30		Drug product	2021-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208743-001	11782041	2038-04-30	U-2009	Drug product	2023-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208743-001	11782041	2038-04-30	U-3543	Drug product	2023-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208743-001	11977067	2038-04-30		Drug product	2024-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208743-001	11255842	2040-01-10	U-3322		2022-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208743-001	11680942	2040-01-10	U-3322		2023-07-20	`caaa826d4ba7…`
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…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 65 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208743-001	I-907	2025-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208743-001	I-907	2025-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208743-001	I-907	2025-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208743-001	I-907	2025-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208743-001	M-270	2024-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208743-001	I-907	2025-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208743-001	M-270	2024-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208743-001	I-907	2025-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208743-001	M-270	2024-09-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208743-001	I-907	2025-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208743-001	M-270	2024-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208743-001	I-907	2025-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208743-001	M-270	2024-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208743-001	I-907	2025-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208743-001	M-270	2024-09-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208743-001	I-907	2025-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208743-001	M-270	2024-09-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208743-001	I-907	2025-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208743-001	M-270	2024-09-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208743-001	I-907	2025-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208743-001	M-270	2024-09-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208743-001	I-907	2025-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208743-001	NCE	2022-04-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208743-001	M-270	2024-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208743-001	NCE	2022-04-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208743-001	M-270	2024-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208743-001	NCE	2022-04-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208743-001	M-270	2024-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208743-001	NCE	2022-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208743-001	NCE	2022-04-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208743-001	M-270	2024-09-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208743-001	NCE	2022-04-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208743-001	M-270	2024-09-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208743-001	NCE	2022-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208743-001	NCE	2022-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208743-001	NCE	2022-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208743-001	NCE	2022-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208743-001	NCE	2022-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208743-001	NCE	2022-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208743-001	NCE	2022-04-28	`ea99ee380514…`

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
Tymlos	ABALOPARATIDE	Radius Health, Inc.	712143d9-e21e-4013-bb3b-3426a21060a8	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208743 application number: NDA208743 ndc (product): 70539-001

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84393	SUPPL	2026-03-02
81894	SUPPL	2025-04-09
81817	SUPPL	2025-04-03
77142	SUPPL	2023-12-27
77113	SUPPL	2023-12-27
72968	SUPPL	2022-12-21
72967	SUPPL	2022-12-21
69754	SUPPL	2021-12-23
69160	SUPPL	2021-10-29
68695	SUPPL	2021-09-21
68682	SUPPL	2021-09-21
68681	SUPPL	2021-09-21
65038	SUPPL	2020-10-27
65037	SUPPL	2020-10-27
65033	SUPPL	2020-10-27
56059	SUPPL	2018-10-23
56014	SUPPL	2018-10-18
54745	SUPPL	2018-07-04
54704	SUPPL	2018-06-27
52539	SUPPL	2018-02-09
52396	SUPPL	2018-02-05
48681	ORIG	2017-06-08
48680	ORIG	2017-06-08
48159	ORIG	2017-04-28
48158	ORIG	2017-04-28
48157	ORIG	2017-04-28