Details for New Drug Application (NDA): 208888
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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 208888
Tradename: | DOXORUBICIN HYDROCHLORIDE |
Applicant: | Amneal |
Ingredient: | doxorubicin hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 208888
Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 208888
Suppliers and Packaging for NDA: 208888
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXORUBICIN HYDROCHLORIDE | doxorubicin hydrochloride | INJECTABLE;INJECTION | 208888 | ANDA | Amneal Pharmaceuticals LLC | 70121-1218 | 70121-1218-7 | 10 CARTON in 1 CARTON (70121-1218-7) / 1 VIAL in 1 CARTON (70121-1218-1) / 10 mL in 1 VIAL |
DOXORUBICIN HYDROCHLORIDE | doxorubicin hydrochloride | INJECTABLE;INJECTION | 208888 | ANDA | Amneal Pharmaceuticals LLC | 70121-1219 | 70121-1219-1 | 1 VIAL in 1 CARTON (70121-1219-1) / 25 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/VIAL | ||||
Approval Date: | Feb 17, 2017 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/VIAL | ||||
Approval Date: | Feb 17, 2017 | TE: | AP | RLD: | No |
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