Home Applications 202344 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 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 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 2 of 2 · 44 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 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…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N202344-001 BINOSTO EQ 70MG BASE TABLET, EFFERVESCENT / ORAL RLD 2012-03-12 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 84 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 N202344-001 9592195 2031-12-05 Drug product 2021-05-12 c2088c7a36db…2026-09-14 22:38:34 2026-08 N202344-001 9592195 2031-12-05 Drug product 2021-05-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202344-001 9592195 2031-12-05 Drug product 2021-05-12 caaa826d4ba7…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…
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
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 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