Application 090886

Type: ANDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISEDRONATE SODIUM	RISEDRONATE SODIUM	TABLET;ORAL	5MG	No	No
002	RISEDRONATE SODIUM	RISEDRONATE SODIUM	TABLET;ORAL	30MG	No	No
003	RISEDRONATE SODIUM	RISEDRONATE SODIUM	TABLET;ORAL	35MG	No	No
004	RISEDRONATE SODIUM	RISEDRONATE SODIUM	TABLET;ORAL	75MG	No	No
005	RISEDRONATE SODIUM	RISEDRONATE SODIUM	TABLET;ORAL	150MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090886-001	RISEDRONATE SODIUM	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30
A090886-002	RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30
A090886-003	RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30
A090886-004	RISEDRONATE SODIUM	RISEDRONATE SODIUM	75MG	TABLET / ORAL	AB	2014-06-10
A090886-005	RISEDRONATE SODIUM	RISEDRONATE SODIUM	150MG	TABLET / ORAL	AB	2014-06-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A090886-001	AB
A090886-002	AB
A090886-003	AB
A090886-004	AB
A090886-005	AB

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 4 of 6 · 220 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
2021-03-12 10:30 UTC	2021-03	A090886-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090886-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090886-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090886-004	RISEDRONATE SODIUM	75MG	TABLET / ORAL	AB	2014-06-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090886-005	RISEDRONATE SODIUM	150MG	TABLET / ORAL	AB	2014-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090886-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090886-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090886-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090886-004	RISEDRONATE SODIUM	75MG	TABLET / ORAL	AB	2014-06-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090886-005	RISEDRONATE SODIUM	150MG	TABLET / ORAL	AB	2014-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090886-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090886-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090886-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090886-004	RISEDRONATE SODIUM	75MG	TABLET / ORAL	AB	2014-06-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090886-005	RISEDRONATE SODIUM	150MG	TABLET / ORAL	AB	2014-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090886-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090886-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090886-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090886-004	RISEDRONATE SODIUM	75MG	TABLET / ORAL	AB	2014-06-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090886-005	RISEDRONATE SODIUM	150MG	TABLET / ORAL	AB	2014-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090886-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090886-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090886-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090886-004	RISEDRONATE SODIUM	75MG	TABLET / ORAL	AB	2014-06-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090886-005	RISEDRONATE SODIUM	150MG	TABLET / ORAL	AB	2014-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090886-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090886-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090886-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090886-004	RISEDRONATE SODIUM	75MG	TABLET / ORAL	AB	2014-06-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090886-005	RISEDRONATE SODIUM	150MG	TABLET / ORAL	AB	2014-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090886-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090886-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090886-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090886-004	RISEDRONATE SODIUM	75MG	TABLET / ORAL	AB	2014-06-10	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090886-005	RISEDRONATE SODIUM	150MG	TABLET / ORAL	AB	2014-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090886-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090886-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090886-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090886-004	RISEDRONATE SODIUM	75MG	TABLET / ORAL	AB	2014-06-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090886-005	RISEDRONATE SODIUM	150MG	TABLET / ORAL	AB	2014-06-10	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A090886-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090886-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090886-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090886-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090886-005	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090886-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090886-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090886-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090886-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090886-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090886-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090886-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090886-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090886-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090886-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090886-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090886-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090886-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090886-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090886-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090886-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090886-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090886-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090886-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090886-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090886-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090886-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090886-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090886-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090886-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090886-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090886-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090886-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090886-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090886-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090886-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090886-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090886-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090886-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090886-005	AB	1	`b8a1b40f171c…`

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	Sun Pharmaceutical Industries, Inc.	e0b5f0ed-ff40-4f0d-bb86-81a7ace9f339	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090886 application number: ANDA090886 ndc (product): 47335-668 ndc (product): 47335-666 ndc (product): 47335-727 ndc (product): 47335-928 ndc (product): 47335-667

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-666	risedronate sodium	risedronate sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-666	risedronate sodium	risedronate sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-666	risedronate sodium	risedronate sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-667	risedronate sodium	risedronate sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-667	risedronate sodium	risedronate sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-667	risedronate sodium	risedronate sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-668	risedronate sodium	risedronate sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-668	risedronate sodium	risedronate sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-668	risedronate sodium	risedronate sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-727	risedronate sodium	risedronate sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-727	risedronate sodium	risedronate sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-727	risedronate sodium	risedronate sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-928	risedronate sodium	risedronate sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-928	risedronate sodium	risedronate sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-928	risedronate sodium	risedronate sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current