Application 050734
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IDAMYCIN PFS | IDARUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | Yes | Yes |
| 002 | IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 10MG/10ML (1MG/ML) | Yes | Yes |
| 003 | IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 20MG/20ML (1MG/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0013-2576 | Idamycin PFS | idarubicin hydrochloride | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0013-2576 | Idamycin PFS | idarubicin hydrochloride | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0013-2576 | Idamycin PFS | idarubicin hydrochloride | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0013-2576 | Idamycin PFS | idarubicin hydrochloride | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0013-2576 | Idamycin PFS | idarubicin hydrochloride | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0013-2576 | Idamycin PFS | idarubicin hydrochloride | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0013-2586 | Idamycin PFS | idarubicin hydrochloride | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0013-2586 | Idamycin PFS | idarubicin hydrochloride | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0013-2586 | Idamycin PFS | idarubicin hydrochloride | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0013-2586 | Idamycin PFS | idarubicin hydrochloride | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0013-2586 | Idamycin PFS | idarubicin hydrochloride | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0013-2586 | Idamycin PFS | idarubicin hydrochloride | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0013-2596 | Idamycin PFS | idarubicin hydrochloride | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0013-2596 | Idamycin PFS | idarubicin hydrochloride | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0013-2596 | Idamycin PFS | idarubicin hydrochloride | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0013-2596 | Idamycin PFS | idarubicin hydrochloride | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0013-2596 | Idamycin PFS | idarubicin hydrochloride | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0013-2596 | Idamycin PFS | idarubicin hydrochloride | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84965 | SUPPL | 2026-02-06 |
| 84963 | SUPPL | 2026-02-06 |
| 76870 | SUPPL | 2023-12-15 |
| 76852 | SUPPL | 2023-12-15 |
| 70863 | SUPPL | 2022-04-29 |
| 70839 | SUPPL | 2022-04-27 |
| 66248 | SUPPL | 2021-02-17 |
| 66194 | SUPPL | 2021-02-11 |
| 59575 | SUPPL | 2019-08-05 |
| 59573 | SUPPL | 2019-08-05 |
| 39217 | SUPPL | 2015-01-09 |
| 8146 | SUPPL | 2014-12-05 |
| 8145 | SUPPL | 2003-05-30 |
| 18144 | SUPPL | 2003-05-06 |