Application 207516

Type: ANDA
Sponsor: HANGZHOU BINJIANG

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISEDRONATE SODIUM	RISEDRONATE SODIUM	TABLET;ORAL	35MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207516-001	RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET / ORAL			2019-02-15

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-02-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207516-001	RISEDRONATE SODIUM	35MG	TABLET / ORAL		2019-02-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A207516-001	AB	1	`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
Risedronate Sodium	RISEDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd	d60a56cb-ef49-4447-9043-7b6879a20d75	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207516 application number: ANDA207516 ndc (product): 60723-041

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60723-041	Risedronate Sodium	Risedronate Sodium	Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd	ANDA	Current
60723-041	Risedronate Sodium	Risedronate Sodium	Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd	ANDA	Current
60723-041	Risedronate Sodium	Risedronate Sodium	Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd	ANDA	Current
60723-041	Risedronate Sodium	Risedronate Sodium	Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd	ANDA	Current
60723-041	Risedronate Sodium	Risedronate Sodium	Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd	ANDA	Current