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FDA Approval

Clofarabine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Dr.Reddy's Laboratories Inc
DUNS: 802315887
Effective Date
July 27, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Clofarabine(1 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Gland Pharma Ltd

Dr.Reddy's Laboratories Inc

650540227

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Clofarabine

Product Details

NDC Product Code
43598-309
Application Number
ANDA205375
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
July 27, 2022
Code: 762RDY0Y2HClass: ACTIBQuantity: 1 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
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