The document specifies Fidaxomicin Tablets as 200 mg but does not detail administration frequency, duration, or patient-specific adjustments.

Dosage Specifications and Clinical Considerations

The approved ANDA confirms the dosage form as Fidaxomicin Tablets, 200 mg, bioequivalent to the reference drug Dificid. However, the document lacks explicit guidance on dosing intervals (e.g., once or twice daily), treatment duration, or adjustments for renal/hepatic impairment. Clinicians should refer to the RLD’s prescribing information for standard protocols. No pediatric or geriatric-specific recommendations are mentioned. The absence of detailed pharmacokinetic or pharmacodynamic data in the approval letter necessitates reliance on existing clinical guidelines for safe dosing.