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DOCIVYX (NDA215813)- (20MG/2ML (10MG/ML),80MG/8ML (10MG/ML),160MG/16ML (10MG/ML),160MG/16ML)

DOCETAXEL AVYXA HOLDINGS
20MG/2ML (10MG/ML),80MG/8ML (10MG/ML),160MG/16ML (10MG/ML),160MG/16ML
No Yes
2036-Mar-14 Expired
None None
None No
Docetaxel Injection is a microtubule inhibitor indicated for: • Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC • Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC • Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer • Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction • Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN.
0 0 0
Total Other Developers None
Drugs with Suitability No
20MG/2ML (10MG/ML) ** ** - - -
80MG/8ML (10MG/ML) ** ** - - -
160MG/16ML (10MG/ML) ** ** - - -
160MG/16ML ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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