Source: FDA, National Drug Code (US) Revision Year: 2023
Teplizumab-mzwv is a CD3-directed monoclonal antibody (humanized IgG1 kappa) that has a molecular weight of approximately 150 kilodalton (kDa) and is expressed from a recombinant Chinese hamster ovary (CHO) cell line.
TZIELD (teplizumab-mzwv) injection is supplied as a sterile, preservative-free, clear and colorless solution in a 2 mg/2 mL (1 mg/mL) single-dose vial for intravenous use. Each mL contains 1 mg of teplizumab-mzwv, dibasic sodium phosphate (0.26 mg), monobasic sodium phosphate (0.98 mg), polysorbate 80 (0.05 mg), sodium chloride (8.78 mg), and water for injection. The pH is 6.1.
| Dosage Forms and Strengths |
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Injection: 2 mg per 2 mL (1 mg/mL) clear and colorless solution in a single-dose vial. |
| How Supplied | ||||||||
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TZIELD (teplizumab-mzwv) injection is a clear and colorless solution (2 mg/2 mL (1 mg/mL)) supplied in a single-dose vial as follows:
Manufactured by: Provention Bio, Inc., Bridgewater, NJ 08807 |
| Drug | Countries | |
|---|---|---|
| TZIELD | United States |
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