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NDA 21107/S012 Page 4 PRESCRIBING INFORMATION (hydrochloride) Tablets WARNING: Infrequent but serious gastrointestinal adverse events have been reported with the use of. These events, including ischemic
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Prescribing information capsules 1 include details about a medication, such as its indications, contraindications, dosage instructions, and side effects.
The pharmaceutical company or drug manufacturer responsible for producing the medication is required to file the prescribing information capsules 1.
The prescribing information capsules 1 can be filled out by providing accurate and comprehensive information about the medication, following the guidelines provided by the regulatory authorities.
The purpose of prescribing information capsules 1 is to inform healthcare professionals and patients about the safe and effective use of a medication, enabling them to make informed decisions about its usage.
Prescribing information capsules 1 must include details about the medication's indications, contraindications, dosage instructions, side effects, warnings, precautions, and any other relevant information.
The specific deadline to file prescribing information capsules 1 in 2023 may vary depending on the applicable regulations and jurisdiction. It is advised to consult the regulatory authorities or legal experts for the accurate deadline information.
The penalty for the late filing of prescribing information capsules 1 may vary depending on the applicable regulations and jurisdiction. It is advised to consult the regulatory authorities or legal experts for the accurate penalty information.
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