Application 205280

Type: ANDA
Sponsor: ORCHID HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISEDRONATE SODIUM	RISEDRONATE SODIUM	TABLET;ORAL	30MG	No	No
002	RISEDRONATE SODIUM	RISEDRONATE SODIUM	TABLET;ORAL	35MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205280-001	RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB		2019-05-13
A205280-002	RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB		2019-05-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A205280-001	AB
A205280-002	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 1 of 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205280-001	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2019-05-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205280-002	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2019-05-13	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205280-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205280-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205280-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205280-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205280-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205280-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205280-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205280-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205280-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205280-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205280-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205280-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205280-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205280-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205280-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205280-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205280-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205280-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205280-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205280-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205280-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205280-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205280-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205280-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205280-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205280-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205280-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205280-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205280-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205280-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205280-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205280-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205280-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205280-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205280-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205280-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205280-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205280-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205280-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205280-002	AB	1	`782e0a99824c…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risedronate Sodium	RISEDRONATE SODIUM	Teva Pharmaceuticals USA, Inc.	dddcd321-4d2e-4643-bf3c-7b752b33ba39	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
Risedronate Sodium	RISEDRONATE SODIUM	Apotex Corp.	b90f2e5b-10b8-29a7-0360-31bd0dae0ec2	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
Risedronate Sodium	RISEDRONATE SODIUM	Macleods Pharmaceuticals Limited	62aff8d6-a2f7-4c7e-a102-c70105ac3792	2026-03-01	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
risedronate sodium	RISEDRONATE SODIUM	Sun Pharmaceutical Industries, Inc.	e0b5f0ed-ff40-4f0d-bb86-81a7ace9f339	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: risedronate sodium generic name: RISEDRONATE SODIUM
Risedronate Sodium	RISEDRONATE SODIUM	Mylan Pharmaceuticals, Inc.	f715718a-407d-4e2a-9834-74a8f1361d03	2026-02-12	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
Risedronate Sodium	RISEDRONATE SODIUM	Aurobindo Pharma Limited	89896dfe-f69d-4cb3-bb71-7a7c611071fa	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
Risedronate Sodium	RISEDRONATE SODIUM	Aurobindo Pharma Limited	a42a35e6-3e08-4b4f-ae56-47d4aec2322a	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
Actonel	RISEDRONATE SODIUM	Allergan, Inc.	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: RISEDRONATE SODIUM
Atelvia	RISEDRONATE SODIUM	Allergan, Inc.	c8b9ab88-1a26-46c3-80ec-4eaa45202021	2026-02-03	Warnings, Adverse reactions	Name fallback generic name: RISEDRONATE SODIUM
Risedronate Sodium	RISEDRONATE SODIUM	Mylan Pharmaceuticals, Inc.	c89430be-15f1-4b8b-ab7e-738de716ee7d	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
Risedronate Sodium	RISEDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd	d60a56cb-ef49-4447-9043-7b6879a20d75	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
Risedronate Sodium	RISEDRONATE SODIUM	Proficient Rx LP	81702f21-3117-49ce-8e9b-2aa2648ba7c3	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
RISEDRONATE SODIUM	RISEDRONATE SODIUM	Sun Pharmaceutical Industires Inc.	1d9e520b-2fa6-4603-b397-f0fc24fae775	2020-09-09	Warnings, Adverse reactions	Name fallback brand name: RISEDRONATE SODIUM generic name: RISEDRONATE SODIUM