Details for New Drug Application (NDA): 050734
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NDA 050734 describes IDAMYCIN PFS, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. Additional details are available on the IDAMYCIN PFS profile page.
The generic ingredient in IDAMYCIN PFS is idarubicin hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the idarubicin hydrochloride profile page.
The generic ingredient in IDAMYCIN PFS is idarubicin hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the idarubicin hydrochloride profile page.
Summary for 050734
| Tradename: | IDAMYCIN PFS |
| Applicant: | Pfizer |
| Ingredient: | idarubicin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 050734
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 050734
Suppliers and Packaging for NDA: 050734
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IDAMYCIN PFS | idarubicin hydrochloride | INJECTABLE;INJECTION | 050734 | NDA | Pfizer Laboratories Div Pfizer Inc | 0013-2576 | 0013-2576-05 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2576-05) / 5 mL in 1 VIAL, SINGLE-DOSE |
| IDAMYCIN PFS | idarubicin hydrochloride | INJECTABLE;INJECTION | 050734 | NDA | Pfizer Laboratories Div Pfizer Inc | 0013-2576 | 0013-2576-91 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2576-91) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Feb 17, 1997 | TE: | AP | RLD: | Yes | ||||
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