# IDAMYCIN PFS / IDARUBICIN HYDROCHLORIDE — FDA application NDA050734

Informational only - not investment advice.

Application NDA050734 · type NDA · FDA status: approved · original approval 1997-02-17

Listed sponsor: PFIZER · [PFE company profile](/company/PFE/) · 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 | IDAMYCIN PFS | IDARUBICIN HYDROCHLORIDE | SOLUTION | INTRAVENOUS | 5MG/5ML (1MG/ML) | Prescription | AP | Yes |
| 002 | IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | SOLUTION | INTRAVENOUS | 10MG/10ML (1MG/ML) | Prescription | AP | Yes |
| 003 | IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | SOLUTION | INTRAVENOUS | 20MG/20ML (1MG/ML) | Prescription | AP | 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

- IDARUBICIN HYDROCHLORIDE · UNII 5VV3MDU5IE · [lmmol compound JVHPTYWUBOQMBP-RVFAQHLVSA-N](https://lmmol.com/compound/JVHPTYWUBOQMBP-RVFAQHLVSA-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/PFE/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

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:NDA050734. FDA data retrieved 2026-08-07.

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