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FDA ANDA 212299, DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), ZYDUS LIFESCIENCES, 09/10/2020
FDA ANDA 212299, DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), ZYDUS LIFESCIENCES, 09/10/2020
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Contents: Approval letter, executive summary, quality assessment data sheets
ANDA: 212299
Company: ZYDUS LIFESCIENCES
Drug Name: DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Active Ingredients: DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Strength: 20MG/10ML (2MG/ML)
Dosage Form/Route: INJECTABLE, LIPOSOMAL;INJECTION
Action Date: 09/10/2020
Marketing Status: Prescription
Submission Classification: ORIG-1
230 Pages
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