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Cladribine

CLADRIBINE INJECTION

Approved
Approval ID

5736aecc-cc1d-47dd-86c0-5fb2e9d70f61

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 19, 2023

Manufacturers
FDA

Hikma Pharmaceuticals USA Inc.

DUNS: 001230762

Products 1

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

Cladribine

PRODUCT DETAILS

NDC Product Code0143-9871
Application NumberANDA075405
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateApril 19, 2023
Generic NameCladribine

INGREDIENTS (4)

CLADRIBINEActive
Quantity: 1 mg in 1 mL
Code: 47M74X9YT5
Classification: ACTIB
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT

Drug Labeling Information

REFERENCES SECTION

LOINC: 34093-5Updated: 4/19/2023

REFERENCES

  1. Santana VM, Mirro J, Harwood FC, et al: A phase I clinical trial of 2-Chloro-deoxyadenosine in pediatric patients with acute leukemia. J. Clin. Onc., 9: 416 (1991).

  2. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U. S. Government Printing Office, Washington, D. C. 20402.

  3. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics, JAMA, March 15 (1985).

  4. National Study Commission on Cytotoxic Exposure--Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.

  5. Clinical Oncological Society of Australia: Guidelines and Recommendations for Safe Handling of Antineoplastic Agents, Med. J. Australia 1:425 (1983).

  6. Jones RB, et al. Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. Ca--A Cancer Journal for Clinicians, Sept/Oct. 258-263 (1983).

  7. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic Drugs in Hospitals. Am. J. Hosp. Pharm., 42:131 (1985).

  8. OSHA Work-Practice Guidelines for Personnel Dealing with Cytotoxic (antineoplastic) Drugs. Am. J. Hosp. Pharm., 43:1193 (1986).

†Viaflex® containers, manufactured by Baxter Healthcare Corporation - Code No. 2B8013 (tested in 1991)

‡MEDICATION CASSETTE™ Reservoir, manufactured by SIMS Deltec, Inc. - Reorder No. 602100A (tested in 1991)

Manufactured by
THYMOORGAN PHARMAZIE GmbH,
Schiffgraben 23, 38690 Goslar, Germany

Distributed by
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922

Revised March 2020

127.207.019/02

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Cladribine - FDA Approval | MedPath