Application 021575

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOSAMAX	ALENDRONATE SODIUM	SOLUTION;ORAL	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021575-001	FOSAMAX	ALENDRONATE SODIUM	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-17

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021575-001	FOSAMAX	EQ 70MG BASE/75ML	SOLUTION / ORAL	RLD	2003-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021575-001	FOSAMAX	EQ 70MG BASE/75ML	SOLUTION / ORAL	RLD	2003-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2003-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2003-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2003-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2003-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2003-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2003-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2003-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2003-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2003-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`f41ea6bd6efb…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021575-001	5994329*PED	2019-01-17	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021575-001	6015801*PED	2019-01-17	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021575-001	6225294*PED	2019-01-17	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021575-001	5994329*PED	2019-01-17	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021575-001	6015801*PED	2019-01-17	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021575-001	6225294*PED	2019-01-17	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021575-001	5994329*PED	2019-01-17	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021575-001	6015801*PED	2019-01-17	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021575-001	6225294*PED	2019-01-17	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021575-001	5994329*PED	2019-01-17	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021575-001	6015801*PED	2019-01-17	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021575-001	6225294*PED	2019-01-17	Pediatric extension	`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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alendronate Sodium	ALENDRONATE SODIUM	Amneal Pharmaceuticals of New York LLC	c23fb7fe-c6b9-4f77-bde7-992222b589d3	2021-02-02	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56352	SUPPL	2018-11-08
28172	SUPPL	2015-12-01
15817	SUPPL	2015-12-01
28171	SUPPL	2015-04-13
37275	SUPPL	2015-04-10
28170	SUPPL	2013-12-26
15816	SUPPL	2013-12-24
37274	SUPPL	2013-04-23
28169	SUPPL	2013-04-23
23286	ORIG	2012-06-29
28167	SUPPL	2012-02-08
37273	SUPPL	2012-02-06
5778	SUPPL	2011-07-06
5777	SUPPL	2011-01-28
15815	SUPPL	2011-01-26
28168	SUPPL	2010-03-05
28166	SUPPL	2010-03-05
5776	SUPPL	2010-03-05
37272	SUPPL	2010-03-02
15814	SUPPL	2010-03-02
15813	SUPPL	2010-03-02
37271	SUPPL	2008-11-07
28165	SUPPL	2008-10-09
42216	SUPPL	2008-07-31
23669	ORIG	2008-01-07
21742	SUPPL	2007-07-06
37270	SUPPL	2007-01-08
28164	SUPPL	2007-01-08
15812	SUPPL	2007-01-08
5775	SUPPL	2007-01-08
28162	SUPPL	2006-01-06
42217	SUPPL	2006-01-05
28163	SUPPL	2005-11-08
37269	SUPPL	2005-11-03
21741	ORIG	2005-04-08
37268	SUPPL	2004-12-08
15811	SUPPL	2004-12-08
5774	SUPPL	2004-12-08
5773	SUPPL	2004-12-08
37267	SUPPL	2004-05-03
28161	SUPPL	2004-04-29
5772	SUPPL	2004-04-20
15810	SUPPL	2004-04-05
5771	SUPPL	2004-03-03
28160	ORIG	2003-09-25
15809	ORIG	2003-09-25