The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Sirolimus (NDC 65841-772). 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.
Sirolimus Tablets, 0.5 mg
NDC 65841-771-01
100 Tablets
Rx only
Sirolimus Tablets, 0.5 mg (1181ca88 F146 43c0 84c6 8fb6d5b84267 01)
Sirolimus Tablets, 1 mg
NDC 65841-772-01
100 Tablets
Rx only
1 mg Label (1181ca88 F146 43c0 84c6 8fb6d5b84267 02)
Sirolimus Tablets, 2 mg
NDC 65841-773-01
100 Tablets
Rx only
2 mg Label (1181ca88 F146 43c0 84c6 8fb6d5b84267 03)
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