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8.3 Females and Males of Reproductive Potential Under current FDA labeling, this subsection may include information about: Pregnancy testing Contraception Infertility This section is included when a medication may affect pregnancy status, fertility, embryo-fetal development, or reproductive decision-making

Filtered the solid, washed with MTBE and dried to get title compound

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A prescription for a compounded version is no longer an automatic substitute for an FDA-approved brand-name medication