The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Bosentan (NDC 70771-1908). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
NDC 70771-1908-8
Bosentan Tablets for Oral Suspension, 32 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Phenylketonurics: Contains Phenylalanine 2.08 mg per tablet for oral suspension.
56 Tablets (4 x 14 unit-dose)
Rx only
Zydus
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