Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Dr. Reddy’s Laboratories Limited
650562841
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Natco Pharma Ltd
BluePoint Laboratories
Dr. Reddy’s Laboratories Limited
918588174
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Doxorubicin Hydrochloride
Product Details
NDC Product Code
68001-345Application Number
ANDA208657Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
September 28, 2022AMMONIUM SULFATEInactive
Code: SU46BAM238Class: IACT
HISTIDINEInactive
Code: 4QD397987EClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
CHOLESTEROLInactive
Code: 97C5T2UQ7JClass: IACT
SODIUM N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINEInactive
Code: 3L6NN8ZZKUClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
HYDROGENATED SOYBEAN LECITHINInactive
Code: H1109Z9J4NClass: IACT
DoxorubicinActive
Code: 82F2G7BL4EClass: ACTIBQuantity: 2 mg in 1 mL