Application 202344

Type: NDA
Sponsor: ASCEND THERAPS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BINOSTO	ALENDRONATE SODIUM	TABLET, EFFERVESCENT;ORAL	EQ 70MG BASE	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
N202344-001	BINOSTO	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL		RLD	2012-03-12

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202344-001	9592195	2031-12-05		Drug product	2021-05-12

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`3f01610625f2…`

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
Binosto	ALENDRONATE SODIUM	Radius Health, Inc.	09765234-01bc-40f7-b9bb-c167056f3909	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202344 application number: NDA202344

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
0178-0101	Binosto	alendronate sodium	Mission Pharmacal Company	NDA	Current
17139-400	Binosto	alendronate sodium	ASCEND Therapeutics	NDA	Current
17139-400	Binosto	alendronate sodium	ASCEND Therapeutics U.S., LLC	NDA	Current
17139-400	Binosto	alendronate sodium	ASCEND Therapeutics	NDA	Current
17139-400	Binosto	alendronate sodium	ASCEND Therapeutics	NDA	Current
17139-400	Binosto	alendronate sodium	ASCEND Therapeutics	NDA	Current
17139-400	Binosto	alendronate sodium	ASCEND Therapeutics	NDA	Current
17139-400	Binosto	alendronate sodium	ASCEND Therapeutics U.S., LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84932	SUPPL	2026-02-05
84920	SUPPL	2026-02-05
84933	SUPPL	2026-02-03
64922	SUPPL	2020-10-15
64919	SUPPL	2020-10-14
63464	SUPPL	2020-06-09
63463	SUPPL	2020-06-09
56235	SUPPL	2018-11-01
46650	SUPPL	2017-01-03
46634	SUPPL	2017-01-03
32247	SUPPL	2016-03-24
32246	SUPPL	2015-04-13
19334	SUPPL	2015-04-10
19333	SUPPL	2015-03-03
32245	SUPPL	2015-02-27
19332	SUPPL	2013-08-09
44854	ORIG	2013-04-29
43398	ORIG	2013-04-29
40173	SUPPL	2013-04-23
10034	SUPPL	2013-04-23
24102	ORIG	2012-08-30
19331	ORIG	2012-08-30
32244	ORIG	2012-03-26