Application 020835

Type: NDA
Sponsor: APIL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACTONEL	RISEDRONATE SODIUM	TABLET;ORAL	30MG	Yes	No
002	ACTONEL	RISEDRONATE SODIUM	TABLET;ORAL	5MG	Yes	No
003	ACTONEL	RISEDRONATE SODIUM	TABLET;ORAL	35MG	Yes	Yes
004	ACTONEL	RISEDRONATE SODIUM	TABLET;ORAL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	ACTONEL	RISEDRONATE SODIUM	TABLET;ORAL	150MG	Yes	Yes

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

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	RLD / RS	Approval date
N020835-001	ACTONEL	RISEDRONATE SODIUM	30MG	TABLET / ORAL		RLD	1998-03-27
N020835-002	ACTONEL	RISEDRONATE SODIUM	5MG	TABLET / ORAL		RLD	2000-04-14
N020835-003	ACTONEL	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	RLD, RS	2002-05-25
N020835-004	ACTONEL	RISEDRONATE SODIUM	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-04-16
N020835-005	ACTONEL	RISEDRONATE SODIUM	150MG	TABLET / ORAL	AB	RLD, RS	2008-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020835-003	AB
N020835-005	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 1 of 6 · 205 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
2026-02-19 14:30 UTC	2026-02	N020835-001	ACTONEL	30MG	TABLET / ORAL		RLD	1998-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020835-002	ACTONEL	5MG	TABLET / ORAL		RLD	2000-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020835-003	ACTONEL	35MG	TABLET / ORAL	AB	RLD, RS	2002-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020835-004	ACTONEL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020835-005	ACTONEL	150MG	TABLET / ORAL	AB	RLD, RS	2008-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020835-001	ACTONEL	30MG	TABLET / ORAL		RLD	1998-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020835-002	ACTONEL	5MG	TABLET / ORAL		RLD	2000-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020835-003	ACTONEL	35MG	TABLET / ORAL	AB	RLD, RS	2002-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020835-004	ACTONEL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020835-005	ACTONEL	150MG	TABLET / ORAL	AB	RLD, RS	2008-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020835-001	ACTONEL	30MG	TABLET / ORAL		RLD	1998-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020835-002	ACTONEL	5MG	TABLET / ORAL		RLD	2000-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020835-003	ACTONEL	35MG	TABLET / ORAL	AB	RLD, RS	2002-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020835-004	ACTONEL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020835-005	ACTONEL	150MG	TABLET / ORAL	AB	RLD, RS	2008-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020835-001	ACTONEL	30MG	TABLET / ORAL		RLD	1998-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020835-002	ACTONEL	5MG	TABLET / ORAL		RLD	2000-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020835-003	ACTONEL	35MG	TABLET / ORAL	AB	RLD, RS	2002-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020835-004	ACTONEL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020835-005	ACTONEL	150MG	TABLET / ORAL	AB	RLD, RS	2008-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020835-001	ACTONEL	30MG	TABLET / ORAL		RLD	1998-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020835-002	ACTONEL	5MG	TABLET / ORAL		RLD	2000-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020835-003	ACTONEL	35MG	TABLET / ORAL	AB	RLD, RS	2002-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020835-004	ACTONEL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020835-005	ACTONEL	150MG	TABLET / ORAL	AB	RLD, RS	2008-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020835-001	ACTONEL	30MG	TABLET / ORAL		RLD	1998-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020835-002	ACTONEL	5MG	TABLET / ORAL		RLD	2000-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020835-003	ACTONEL	35MG	TABLET / ORAL	AB	RLD, RS	2002-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020835-004	ACTONEL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020835-005	ACTONEL	150MG	TABLET / ORAL	AB	RLD, RS	2008-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020835-001	ACTONEL	30MG	TABLET / ORAL		RLD	1998-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020835-002	ACTONEL	5MG	TABLET / ORAL		RLD	2000-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020835-003	ACTONEL	35MG	TABLET / ORAL	AB	RLD, RS	2002-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020835-004	ACTONEL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020835-005	ACTONEL	150MG	TABLET / ORAL	AB	RLD, RS	2008-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020835-001	ACTONEL	30MG	TABLET / ORAL		RLD	1998-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020835-002	ACTONEL	5MG	TABLET / ORAL		RLD	2000-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020835-003	ACTONEL	35MG	TABLET / ORAL	AB	RLD, RS	2002-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020835-004	ACTONEL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020835-005	ACTONEL	150MG	TABLET / ORAL	AB	RLD, RS	2008-04-22	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 110 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	N020835-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020835-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020835-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020835-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020835-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020835-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020835-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020835-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020835-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020835-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020835-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020835-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020835-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020835-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020835-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020835-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020835-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020835-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020835-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020835-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020835-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020835-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020835-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020835-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020835-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020835-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020835-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020835-005	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020835-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020835-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020835-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020835-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020835-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020835-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020835-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020835-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020835-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020835-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020835-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020835-005	AB	1	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020835-005	7192938	2023-05-06	U-353		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020835-005	7718634	2023-05-06	U-662		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020835-005	7192938*PED	2023-11-06		Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020835-005	7718634*PED	2023-11-06		Pediatric extension	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020835-005	7192938	2023-05-06	U-353		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020835-005	7718634	2023-05-06	U-662		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020835-005	7192938*PED	2023-11-06		Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020835-005	7718634*PED	2023-11-06		Pediatric extension	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020835-005	7192938	2023-05-06	U-353		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020835-005	7718634	2023-05-06	U-662		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020835-005	7192938*PED	2023-11-06		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020835-005	7718634*PED	2023-11-06		Pediatric extension	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020835-003	5994329*PED	2019-01-17		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020835-003	6015801*PED	2019-01-17		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020835-003	6432932*PED	2019-01-17		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020835-003	6465443*PED	2019-02-14		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020835-005	7192938	2023-05-06	U-353		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020835-005	7718634	2023-05-06	U-662		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020835-005	7192938*PED	2023-11-06		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020835-005	7718634*PED	2023-11-06		Pediatric extension	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020835-005	7192938	2023-05-06	U-353		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020835-005	7718634	2023-05-06	U-662		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020835-005	7192938*PED	2023-11-06		Pediatric extension	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020835-005	7718634*PED	2023-11-06		Pediatric extension	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020835-005	7192938	2023-05-06	U-353		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020835-005	7718634	2023-05-06	U-662		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020835-005	7192938*PED	2023-11-06		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020835-005	7718634*PED	2023-11-06		Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020835-005	7192938	2023-05-06	U-353		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020835-005	7718634	2023-05-06	U-662		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020835-005	7192938*PED	2023-11-06		Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020835-005	7718634*PED	2023-11-06		Pediatric extension	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020835-005	7192938	2023-05-06	U-353		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020835-005	7718634	2023-05-06	U-662		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020835-005	7192938*PED	2023-11-06		Pediatric extension	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020835-005	7718634*PED	2023-11-06		Pediatric extension	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020835-005	7192938	2023-05-06	U-353		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020835-005	7718634	2023-05-06	U-662		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020835-005	7192938*PED	2023-11-06		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020835-005	7718634*PED	2023-11-06		Pediatric extension	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risedronate Sodium	RISEDRONATE SODIUM	Mylan Pharmaceuticals, Inc.	f715718a-407d-4e2a-9834-74a8f1361d03	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020835 application number: NDA020835 ndc (product): 59762-0405 ndc (product): 59762-0406
Actonel	RISEDRONATE SODIUM	Allergan, Inc.	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020835 application number: NDA020835 ndc (product): 0430-0472 ndc (product): 0430-0478 ndc (product): 0430-0470 ndc (product): 0430-0471

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 52 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0149-0470	ACTONEL	RISEDRONATE SODIUM	Warner Chilcott Pharmaceuticals Inc.	NDA	Current
0149-0471	ACTONEL	RISEDRONATE SODIUM	Warner Chilcott Pharmaceuticals Inc.	NDA	Current
0149-0472	ACTONEL	RISEDRONATE SODIUM	Warner Chilcott Pharmaceuticals Inc.	NDA	Current
0149-0478	ACTONEL	RISEDRONATE SODIUM	Warner Chilcott Pharmaceuticals Inc.	NDA	Current
0430-0470	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0470	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0470	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0471	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0471	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0471	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0472	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0472	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0472	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0472	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0472	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0472	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0472	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0478	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0478	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0478	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0478	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0478	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0478	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0430-0478	Actonel	Risedronate Sodium	Allergan, Inc.	NDA	Current
0591-2044	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2044	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2044	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2044	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2067	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2067	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2067	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2067	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2075	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2075	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2075	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2075	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2075	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2102	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2102	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2102	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2109	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2109	risedronate sodium	risedronate sodium	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
59762-0405	Risedronate Sodium	Risedronate Sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0405	Risedronate Sodium	Risedronate Sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0405	Risedronate Sodium	Risedronate Sodium	Greenstone LLC	NDA	Current
59762-0405	Risedronate Sodium	Risedronate Sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0405	Risedronate Sodium	Risedronate Sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0406	Risedronate Sodium	Risedronate Sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0406	Risedronate Sodium	Risedronate Sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0406	Risedronate Sodium	Risedronate Sodium	Greenstone LLC	NDA	Current
59762-0406	Risedronate Sodium	Risedronate Sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0406	Risedronate Sodium	Risedronate Sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84937	SUPPL	2026-02-05
84913	SUPPL	2026-02-05
84938	SUPPL	2026-02-03
61479	SUPPL	2019-12-31
61478	SUPPL	2019-12-31
60791	SUPPL	2019-11-07
46085	SUPPL	2016-12-07
26005	SUPPL	2015-04-13
35476	SUPPL	2015-04-10
13567	SUPPL	2015-03-27
3518	SUPPL	2015-03-27
13566	SUPPL	2013-04-23
3517	SUPPL	2013-04-23
3516	SUPPL	2011-08-24
26004	SUPPL	2011-02-02
3515	SUPPL	2011-02-02
35475	SUPPL	2011-01-31
13565	SUPPL	2011-01-31
26003	SUPPL	2010-01-06
13564	SUPPL	2010-01-04
26002	SUPPL	2009-07-31
13563	SUPPL	2009-07-30
53398	ORIG	2009-04-24
53397	ORIG	2009-04-24
51086	SUPPL	2009-04-24
23604	ORIG	2009-04-24
26001	SUPPL	2008-04-25
3514	SUPPL	2008-04-25
20998	SUPPL	2008-02-19
20997	SUPPL	2008-02-19
20996	SUPPL	2008-02-19
41742	SUPPL	2007-07-27
13562	SUPPL	2007-07-27
3513	SUPPL	2007-07-27
13561	SUPPL	2007-04-20
3512	SUPPL	2007-04-20
26000	SUPPL	2006-08-21
3511	SUPPL	2006-08-21
35474	SUPPL	2006-08-14
13560	SUPPL	2006-08-14
3509	SUPPL	2006-01-30
35472	SUPPL	2006-01-25
35473	SUPPL	2005-09-15
3510	SUPPL	2005-09-15
35471	SUPPL	2005-05-17
25999	SUPPL	2005-05-17
41739	ORIG	2004-05-25
13559	SUPPL	2004-04-05
3508	SUPPL	2004-02-25
35470	SUPPL	2003-05-20
25998	SUPPL	2002-05-17
3507	SUPPL	2002-05-17
41741	SUPPL	2001-08-17
41740	SUPPL	2001-08-17
20995	SUPPL	2001-08-17
20994	SUPPL	2001-08-17
35469	SUPPL	2000-04-14
25997	SUPPL	2000-04-14
25996	SUPPL	2000-04-14
13558	SUPPL	2000-04-14
13557	SUPPL	2000-04-14
13556	SUPPL	2000-04-14
3506	SUPPL	2000-04-14
3505	SUPPL	2000-04-14
3504	ORIG	1998-03-27
64069	ORIG	1900-01-01
64068	ORIG	1900-01-01
64067	ORIG	1900-01-01
54082	SUPPL	1900-01-01
54081	SUPPL	1900-01-01