Details for New Drug Application (NDA): 050467
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NDA 050467 describes DOXORUBICIN HYDROCHLORIDE, which is a drug marketed by Actavis Inc, Almaject, Amneal, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hisun Pharm Hangzhou, Hlthcare, Mylan Labs Ltd, Norvium Bioscience, Pfizer, Pharmachemie Bv, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, Ayana Pharma Ltd, Baxter Hlthcare Corp, Dr Reddys, Lupin, Sun Pharm, and Zydus Lifesciences, and is included in twenty-five NDAs. It is available from ten suppliers. Additional details are available on the DOXORUBICIN HYDROCHLORIDE profile page.
The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
Summary for 050467
| Tradename: | DOXORUBICIN HYDROCHLORIDE |
| Applicant: | Pfizer |
| Ingredient: | doxorubicin hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 050467
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/VIAL | ||||
| Approval Date: | May 20, 1985 | TE: | RLD: | No | |||||
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