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ALENDRONATE SODIUM	SOLUTION;ORAL	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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FOSAMAX	ALENDRONATE SODIUM	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2003-09-17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N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`84e616aacf4f…`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N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`caaa826d4ba7…`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UTC	2026-02	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`011fe1cb6892…`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ZIP	2025-12	N021575-001	FOSAMAX	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2003-09-17	`31067a03dcf5…`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 1 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	REMEDYREPACK INC.	c7e470d6-508e-466e-a78d-060bbbc9745c	2026-07-03	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
ALENDRONATE SODIUM	ALENDRONATE SODIUM	NuCare Pharmaceuticals,Inc.	54d6543d-4239-58b1-e054-00144ff88e88	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
ALENDRONATE SODIUM	ALENDRONATE SODIUM	REMEDYREPACK INC.	c4358ba7-1bf8-4b0a-9407-5ac279d04555	2026-06-22	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	Rising Pharma Holdings, Inc.	ffdd2496-d253-419b-85a6-8c615f7545f1	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	NorthStar Rx LLC	4323d3aa-cbb0-41e2-aba7-7a94a0516993	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	A-S Medication Solutions	d52cf007-5775-4dea-9f43-b1907b6ffe81	2026-05-22	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	Aurobindo Pharma Limited	815a87c4-e489-4eb9-9a2e-fb7a16642f01	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
ALENDRONATE SODIUM	ALENDRONATE SODIUM	Cipla USA Inc.	e2fac28d-ad91-4cdc-a003-9fdeac073f76	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
FOSAMAX	ALENDRONATE SODIUM	Organon LLC	14e931fd-2c5f-4d90-b7db-5980706f4a56	2026-03-12	Warnings, Adverse reactions	Name fallback brand name: FOSAMAX generic name: ALENDRONATE SODIUM
ALENDRONATE SODIUM	ALENDRONATE SODIUM	Preferred Pharmaceuticals Inc.	83e3ba94-d882-4b5c-87cb-af1eb0997efc	2026-02-16	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	A-S Medication Solutions	eeb65442-6b3c-485c-9c5d-9cf40df4451e	2026-02-13	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
Binosto	ALENDRONATE SODIUM	Radius Health, Inc.	09765234-01bc-40f7-b9bb-c167056f3909	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	Hikma Pharmaceuticals USA Inc.	c910bb05-279b-4ffa-a867-46f4a0853ed5	2026-01-15	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
Alendronate	ALENDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	a24fd39c-34a7-4de2-9439-781e612189ca	2025-12-16	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
ALENDRONATE SODIUM	ALENDRONATE SODIUM	A-S Medication Solutions	fe1dd324-eb02-4a73-97f5-9b77a7df10a7	2025-12-05	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	ANI Pharmaceuticals, Inc.	81589178-10c9-4806-91eb-54e638d35b8d	2025-10-29	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
ALENDRONATE SODIUM	ALENDRONATE SODIUM	NuCare Pharmaceuticals, Inc.	2baf8516-4148-9007-e063-6394a90a8094	2025-01-14	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	A-S Medication Solutions	873442b0-1932-4fa6-ba25-b4d3505f4128	2024-11-13	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EXELAN PHARMACEUTICALS INC.	91a0f73a-d8cd-4197-b431-40707a2150b9	2023-08-25	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	Proficient Rx LP	6c4d13fb-490c-4ea9-9b04-003c8d8e9f0c	2023-03-01	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