Details for New Drug Application (NDA): 091418
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The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
Summary for 091418
Tradename: | DOXORUBICIN HYDROCHLORIDE |
Applicant: | Sun Pharm Inds |
Ingredient: | doxorubicin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091418
Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 091418
Suppliers and Packaging for NDA: 091418
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXORUBICIN HYDROCHLORIDE | doxorubicin hydrochloride | INJECTABLE;INJECTION | 091418 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-826 | 62756-826-40 | 1 VIAL, SINGLE-DOSE in 1 BOX (62756-826-40) / 25 mL in 1 VIAL, SINGLE-DOSE |
DOXORUBICIN HYDROCHLORIDE | doxorubicin hydrochloride | INJECTABLE;INJECTION | 091418 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-827 | 62756-827-40 | 1 VIAL, MULTI-DOSE in 1 BOX (62756-827-40) / 100 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
Approval Date: | Feb 15, 2012 | TE: | AP | RLD: | No |
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