Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Inc.
675480402
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Docetaxel
Product Details
NDC Product Code
62332-678Application Number
ANDA215744Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
September 4, 2023DocetaxelActive
Code: 699121PHCAClass: ACTIBQuantity: 10 mg in 1 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQClass: IACT
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
BOXED WARNING SECTION
**WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY
REACTIONS, and FLUID RETENTION**