Approved drug product pdf download

The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug Administration FDA. See 21 CFR part The drug labeling and other information has been reformatted to make it easier to read but its content has neither been altered nor verified by FDA. The drug labeling on this Web site may not be the labeling on currently distributed products or identical to the labeling that is approved.

Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies described in monographs. Drugs marked "unapproved medical gas", "unapproved homeopathic" or "unapproved drug other" on this Web site have not been evaluated by FDA for safety and efficacy and their labeling has not been approved. In addition, FDA is not aware of scientific evidence to support homeopathy as effective.

The device labeling and other device-specific information on this website have been voluntarily submitted to the FDA by device manufacturers. FDA has not reviewed this information prior to posting on this website. In addition, FDA is not aware of scientific evidence to support homeopathy as effective.

The device labeling and other device-specific information on this website have been voluntarily submitted to the FDA by device manufacturers. FDA has not reviewed this information prior to posting on this website. The device labeling has been reformatted to make it easier to read but its content has not been altered nor verified by FDA.

The device labeling on this website may not be the labeling on currently distributed products. Send questions and comments to the SPL Coordinator at spl fda.

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