# FOSAMAX PLUS D — FDA application NDA021762

Informational only - not investment advice.

Application NDA021762 · type NDA · FDA status: approved · original approval 2005-04-07

Listed sponsor: ORGANON LLC · [OGN company profile](/company/OGN/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | FOSAMAX PLUS D | ALENDRONATE SODIUM; CHOLECALCIFEROL | TABLET | ORAL | EQ 70MG BASE;2,800 IU | Prescription | not listed | Yes |
| 002 | FOSAMAX PLUS D | ALENDRONATE SODIUM; CHOLECALCIFEROL | TABLET | ORAL | EQ 70MG BASE;5,600 IU | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

No Orange Book patent or exclusivity listings joined to this application.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- ALENDRONATE SODIUM · UNII 2UY4M2U3RA · no lmmol compound match
- CHOLECALCIFEROL · UNII 1C6V77QF41 · [lmmol compound QYSXJUFSXHHAJI-YRZJJWOYSA-N](https://lmmol.com/compound/QYSXJUFSXHHAJI-YRZJJWOYSA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/OGN/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA021762. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.