Application 021762

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOSAMAX PLUS D	ALENDRONATE SODIUM; CHOLECALCIFEROL	TABLET;ORAL	EQ 70MG BASE;2,800 IU	Yes	No
002	FOSAMAX PLUS D	ALENDRONATE SODIUM; CHOLECALCIFEROL	TABLET;ORAL	EQ 70MG BASE;5,600 IU	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021762-001	FOSAMAX PLUS D	ALENDRONATE SODIUM; CHOLECALCIFEROL	EQ 70MG BASE;2,800 IU	TABLET / ORAL		RLD	2005-04-07
N021762-002	FOSAMAX PLUS D	ALENDRONATE SODIUM; CHOLECALCIFEROL	EQ 70MG BASE;5,600 IU	TABLET / ORAL		RLD, RS	2007-04-26

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`3a93d1ddd44b…`

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	N021762-001	5994329*PED	2019-01-17	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021762-001	5994329*PED	2019-01-17	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021762-001	5994329*PED	2019-01-17	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021762-001	5994329*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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOSAMAX PLUS D	ALENDRONATE SODIUM AND CHOLECALCIFEROL	Organon LLC	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021762 application number: NDA021762 ndc (product): 78206-137 ndc (product): 78206-136

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-0270	FOSAMAX PLUS D	ALENDRONATE SODIUM and CHOLECALCIFEROL	Merck Sharp & Dohme Corp.	NDA	Current
0006-0270	FOSAMAX PLUS D	ALENDRONATE SODIUM and CHOLECALCIFEROL	Merck Sharp & Dohme Corp.	NDA	Current
0006-0270	FOSAMAX PLUS D	ALENDRONATE SODIUM and CHOLECALCIFEROL	Merck Sharp & Dohme Corp.	NDA	Current
0006-0270	FOSAMAX PLUS D	ALENDRONATE SODIUM and CHOLECALCIFEROL	Merck Sharp & Dohme Corp.	NDA	Current
0006-0710	FOSAMAX PLUS D	ALENDRONATE SODIUM and CHOLECALCIFEROL	Merck Sharp & Dohme Corp.	NDA	Current
0006-0710	FOSAMAX PLUS D	ALENDRONATE SODIUM and CHOLECALCIFEROL	Merck Sharp & Dohme Corp.	NDA	Current
0006-0710	FOSAMAX PLUS D	ALENDRONATE SODIUM and CHOLECALCIFEROL	Merck Sharp & Dohme Corp.	NDA	Current
0006-0710	FOSAMAX PLUS D	ALENDRONATE SODIUM and CHOLECALCIFEROL	Merck Sharp & Dohme Corp.	NDA	Current
78206-136	FOSAMAX PLUS D	ALENDRONATE SODIUM and CHOLECALCIFEROL	Organon LLC	NDA	Current
78206-136	FOSAMAX PLUS D	ALENDRONATE SODIUM and CHOLECALCIFEROL	Organon LLC	NDA	Current
78206-136	FOSAMAX PLUS D	ALENDRONATE SODIUM and CHOLECALCIFEROL	Organon LLC	NDA	Current
78206-137	FOSAMAX PLUS D	ALENDRONATE SODIUM and CHOLECALCIFEROL	Organon LLC	NDA	Current
78206-137	FOSAMAX PLUS D	ALENDRONATE SODIUM and CHOLECALCIFEROL	Organon LLC	NDA	Current
78206-137	FOSAMAX PLUS D	ALENDRONATE SODIUM and CHOLECALCIFEROL	Organon LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84931	SUPPL	2026-02-05
84930	SUPPL	2026-02-05
84914	SUPPL	2026-02-05
59790	SUPPL	2019-08-21
59789	SUPPL	2019-08-21
59752	SUPPL	2019-08-20
37604	SUPPL	2015-12-02
6141	SUPPL	2015-12-01
6140	SUPPL	2015-04-13
16330	SUPPL	2015-04-10
37603	SUPPL	2013-11-08
28548	SUPPL	2013-11-08
23296	ORIG	2013-05-09
37602	SUPPL	2013-04-23
28547	SUPPL	2013-04-23
28546	SUPPL	2011-07-06
6139	SUPPL	2011-01-27
37601	SUPPL	2011-01-26
28545	SUPPL	2010-03-03
28544	SUPPL	2010-03-03
6138	SUPPL	2010-03-03
37600	SUPPL	2010-03-02
16329	SUPPL	2010-03-02
16327	SUPPL	2010-03-02
16328	SUPPL	2008-11-07
6137	SUPPL	2008-10-09
44150	ORIG	2008-01-07
28543	SUPPL	2007-05-01
16326	SUPPL	2007-05-01
37599	SUPPL	2007-01-08
37598	SUPPL	2007-01-08
6136	SUPPL	2007-01-08
6135	SUPPL	2007-01-08
21807	ORIG	2006-06-08
37597	SUPPL	2005-11-08
28542	SUPPL	2005-11-08
37596	ORIG	2005-04-12
28541	ORIG	2005-04-12