Application 020560

Type: NDA
Sponsor: MERCK AND CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOSAMAX	ALENDRONATE SODIUM	TABLET;ORAL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	FOSAMAX	ALENDRONATE SODIUM	TABLET;ORAL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	FOSAMAX	ALENDRONATE SODIUM	TABLET;ORAL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	FOSAMAX	ALENDRONATE SODIUM	TABLET;ORAL	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	FOSAMAX	ALENDRONATE SODIUM	TABLET;ORAL	EQ 70MG BASE	Yes	Yes

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

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
N020560-001	FOSAMAX	ALENDRONATE SODIUM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29
N020560-002	FOSAMAX	ALENDRONATE SODIUM	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29
N020560-003	FOSAMAX	ALENDRONATE SODIUM	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25
N020560-004	FOSAMAX	ALENDRONATE SODIUM	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20
N020560-005	FOSAMAX	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020560-005	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 · 210 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
2026-08-18 06:07:40	2026-07	N020560-001	FOSAMAX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020560-002	FOSAMAX	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020560-003	FOSAMAX	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020560-004	FOSAMAX	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020560-001	FOSAMAX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020560-002	FOSAMAX	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020560-003	FOSAMAX	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020560-004	FOSAMAX	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020560-001	FOSAMAX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020560-002	FOSAMAX	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020560-003	FOSAMAX	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020560-004	FOSAMAX	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020560-001	FOSAMAX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020560-002	FOSAMAX	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020560-003	FOSAMAX	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020560-004	FOSAMAX	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020560-001	FOSAMAX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020560-002	FOSAMAX	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020560-003	FOSAMAX	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020560-004	FOSAMAX	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020560-001	FOSAMAX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020560-002	FOSAMAX	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020560-003	FOSAMAX	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020560-004	FOSAMAX	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020560-001	FOSAMAX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020560-002	FOSAMAX	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020560-003	FOSAMAX	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020560-004	FOSAMAX	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020560-001	FOSAMAX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020560-002	FOSAMAX	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020560-003	FOSAMAX	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020560-004	FOSAMAX	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020560-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020560-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020560-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020560-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020560-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020560-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020560-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020560-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020560-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020560-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020560-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020560-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020560-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020560-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020560-005	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020560-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020560-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020560-005	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020560-005	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020560-005	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020560-005	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020560-005	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020560-005	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020560-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020560-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020560-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020560-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020560-005	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020560-005	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020560-005	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020560-005	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020560-005	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020560-005	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020560-005	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020560-005	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020560-005	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020560-005	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020560-005	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020560-005	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020560-005	AB	1	`e64feba35796…`

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
FOSAMAX	ALENDRONATE SODIUM	Organon LLC	14e931fd-2c5f-4d90-b7db-5980706f4a56	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020560 application number: NDA020560 ndc (product): 78206-135

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
0006-0031	FOSAMAX	alendronate sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-0031	FOSAMAX	alendronate sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-0031	FOSAMAX	alendronate sodium	Merck Sharp & Dohme Corp.	NDA	Current
78206-135	FOSAMAX	alendronate sodium	Organon LLC	NDA	Current
78206-135	FOSAMAX	alendronate sodium	Organon LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84928	SUPPL	2026-02-05
84927	SUPPL	2026-02-05
84912	SUPPL	2026-02-05
59795	SUPPL	2019-08-21
59756	SUPPL	2019-08-20
57661	ORIG	2019-02-15
56350	SUPPL	2018-11-08
34838	SUPPL	2015-12-01
2731	SUPPL	2015-12-01
25183	SUPPL	2015-04-13
34837	SUPPL	2015-04-10
25182	SUPPL	2013-12-26
34836	SUPPL	2013-12-24
23163	ORIG	2013-05-09
25181	SUPPL	2013-04-23
12730	SUPPL	2013-04-23
34835	SUPPL	2012-06-28
25180	SUPPL	2012-06-28
2730	SUPPL	2012-02-08
12729	SUPPL	2012-02-06
25179	SUPPL	2011-07-06
25178	SUPPL	2011-01-28
34834	SUPPL	2011-01-26
25177	SUPPL	2010-03-05
25175	SUPPL	2010-03-05
2729	SUPPL	2010-03-05
34833	SUPPL	2010-03-02
34832	SUPPL	2010-03-02
12728	SUPPL	2010-03-02
34831	SUPPL	2008-11-07
25176	SUPPL	2008-10-09
41430	SUPPL	2008-08-08
41428	SUPPL	2008-08-08
20725	SUPPL	2008-08-04
20728	SUPPL	2008-08-01
20727	SUPPL	2008-08-01
20726	SUPPL	2008-08-01
20724	SUPPL	2008-08-01
20723	SUPPL	2008-08-01
41432	SUPPL	2008-07-31
44058	ORIG	2008-01-07
41431	SUPPL	2007-11-19
41429	SUPPL	2007-11-19
20722	SUPPL	2007-11-19
20729	SUPPL	2007-07-06
34830	SUPPL	2007-01-08
25174	SUPPL	2007-01-08
12727	SUPPL	2007-01-08
2728	SUPPL	2007-01-08
25170	SUPPL	2006-01-06
34827	SUPPL	2006-01-05
2727	SUPPL	2005-11-08
12726	SUPPL	2005-11-03
34829	SUPPL	2004-12-08
25173	SUPPL	2004-12-08
12725	SUPPL	2004-12-08
2726	SUPPL	2004-12-08
12722	SUPPL	2004-05-04
12723	SUPPL	2004-05-03
25167	SUPPL	2004-04-29
25172	SUPPL	2004-04-20
12724	SUPPL	2004-04-05
2725	SUPPL	2004-03-03
25171	SUPPL	2003-09-29
34828	SUPPL	2003-09-25
20721	SUPPL	2003-04-30
20720	SUPPL	2003-04-30
25169	SUPPL	2003-03-26
34824	SUPPL	2002-09-16
2723	SUPPL	2002-09-16
25168	SUPPL	2002-08-13
34826	SUPPL	2002-08-05
2724	SUPPL	2002-08-05
34825	SUPPL	2002-07-25
34823	SUPPL	2001-01-31
34822	SUPPL	2001-01-31
25166	SUPPL	2001-01-31
2722	SUPPL	2001-01-31
34821	SUPPL	2000-10-20
25164	SUPPL	2000-10-20
12721	SUPPL	2000-10-20
2721	SUPPL	2000-10-20
25165	SUPPL	2000-09-29
2720	SUPPL	1999-11-24
2719	SUPPL	1999-11-24
41427	SUPPL	1999-06-16
34820	SUPPL	1999-06-16
25163	SUPPL	1999-06-16
20719	SUPPL	1999-06-08
12720	SUPPL	1999-06-08
2718	SUPPL	1999-06-08
41426	SUPPL	1997-04-25
20718	SUPPL	1997-04-25
51765	ORIG	1900-01-01
51764	ORIG	1900-01-01
51763	ORIG	1900-01-01
51762	ORIG	1900-01-01
51761	ORIG	1900-01-01