Drug Safety-related Labeling Changes (SrLC)

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ZYFLO CR (NDA-022052)

(ZILEUTON)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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12/31/2018 (SUPPL-14)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

8.2 Lactation

PLLR conversion; extensive changes. Please refer to label for complete information.

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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