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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 22411 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS EXCLUSIVITY SUMMARY NDA # 22411 SUPPL # 000 HAD # 130 Trade Name ExtendedRelease Tablets

How to fill out trade name extendedrelease tablets

How to fill out trade name extended-release tablets?

1. Start by reading the instructions on the packaging or the prescription label carefully. Familiarize yourself with the specific dosage and administration guidelines.
2. Wash your hands thoroughly with soap and water before handling the tablets. This helps prevent contamination and the transfer of germs.
3. Retrieve the trade name extended-release tablets from their packaging. Make sure to handle them with clean, dry hands to avoid any moisture or dirt on the tablets.
4. Take the prescribed amount of tablets as directed by your healthcare provider. It's important not to exceed or skip any doses unless advised by your doctor.
5. Swallow the tablets whole with a glass of water. Do not chew, crush, or break them unless instructed otherwise. Breaking or crushing the tablets may alter their extended-release properties.
6. If necessary, take the tablets with food to minimize any potential stomach upset. However, follow the instructions provided by your healthcare professional regarding whether to take them with or without food.
7. If you miss a dose, take it as soon as you remember. However, if it is close to the next scheduled dose, it's best to skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.
8. Store the trade name extended-release tablets in a cool, dry place away from direct sunlight and moisture. Keep them out of reach of children to prevent accidental ingestion.

Who needs trade name extended-release tablets?

1. Trade name extended-release tablets are often prescribed by healthcare providers for individuals who require a controlled and extended release of medication over a specific time period.
2. These tablets may be prescribed for individuals with chronic conditions that need consistent and sustained levels of medication in their system.
3. In some cases, trade name extended-release tablets may be prescribed when a once-daily dosing regimen is preferred to enhance patient adherence to the medication.
4. Trade name extended-release tablets can be used to treat various medical conditions, including but not limited to chronic pain, hypertension, diabetes, mental health disorders, and neurological disorders.
5. It is crucial to consult with a healthcare professional to determine whether trade name extended-release tablets are suitable for your specific medical condition and to ensure proper dosing and administration.

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What is trade name extendedrelease tablets?

Trade name extended-release tablets are pharmaceutical tablets that are designed to release the active ingredient slowly over an extended period of time.

Who is required to file trade name extendedrelease tablets?

Pharmaceutical companies or manufacturers are required to file trade name extended-release tablets with the regulatory authorities.

How to fill out trade name extendedrelease tablets?

Trade name extended-release tablets can be filled out by providing information such as the brand name, generic name, dosage strength, and any other relevant details.

What is the purpose of trade name extendedrelease tablets?

The purpose of trade name extended-release tablets is to provide a controlled release of the medication over a longer period of time, resulting in sustained therapeutic effect.

What information must be reported on trade name extendedrelease tablets?

Information such as the active ingredient, dosage strength, formulation, expiration date, and any warnings or precautions must be reported on trade name extended-release tablets.