Get the free Extended Release Generic Name Priority 3 Approval Package - accessdata fda

CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: NDA 21999×S004 Trade Name: Extended Release Generic Name: Sponsor: Johnson & Johnson Pharmaceutical R. & D., LLC

How to fill out extended release generic name

Point by point instructions on how to fill out extended release generic name:

1. Identify the medication: Start by writing down the generic name of the extended release medication you are referring to. This name is usually found on the medication bottle or packaging.
2. Consult the instructions: Read the information provided with the medication carefully. Look for any specific instructions on how to fill out the extended release generic name. This may include dosage, frequency, or any additional steps required.
3. Understand the purpose: Extended release medications are designed to slowly release the active ingredient into the body over an extended period. It is important to understand the purpose of the medication and how it differs from immediate release formulations.
4. Follow the healthcare provider's instructions: Make sure to follow the instructions given to you by your healthcare provider or pharmacist. They will provide specific guidance on how to fill out the extended release generic name based on your individual needs and condition.
5. Note any special considerations: Pay attention to any special considerations mentioned in the instructions. This may include instructions related to food intake, timing of doses, or any possible interactions with other medications.
6. Keep track of your medication: Maintain a record of each time you take the extended release medication. This can help you ensure you are taking it as prescribed and allow you to keep track of any side effects or changes in your symptoms.

Who needs extended release generic name?

1. Patients with chronic conditions: Extended release medications are often prescribed for individuals with chronic conditions that require continuous medication delivery over an extended period. This includes conditions like diabetes, hypertension, or certain psychiatric disorders.
2. Individuals with busy schedules: Extended release medications can be beneficial for individuals who have difficulty adhering to multiple daily doses. With extended release formulations, medication dosing can be reduced to once or twice a day, providing convenience and improved adherence.
3. Patients who require consistent medication levels: Some medications, especially those with a narrow therapeutic range, require a consistent level of the drug in the bloodstream to be effective. Extended release formulations help maintain steady drug levels, minimizing potential fluctuations and optimizing treatment outcomes.

Remember, always consult with your healthcare provider or pharmacist for personalized advice on filling out extended release generic names and determining if they are appropriate for your specific needs.

For pdfFiller’s FAQs

What is extended release generic name?

Extended release generic name is the longer-lasting version of a generic drug.

Who is required to file extended release generic name?

Manufacturers of extended release generic drugs are required to file the generic name.

How to fill out extended release generic name?

Extended release generic name can be filled out by providing the necessary information about the drug's formulation and release mechanism.

What is the purpose of extended release generic name?

The purpose of extended release generic name is to differentiate the drug from its immediate release counterpart and indicate its extended release properties.

What information must be reported on extended release generic name?

The extended release generic name must include information about the drug's active ingredient, dosage form, and release mechanism.

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