Home Applications 021762 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 42 .
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 1 of 3 · 84 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 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 4b0b4de00fa7…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…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date 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.
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