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CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:022225Orig1s000
MICROBIOLOGY / VIROLOGY REVIEW(S)Product Quality Microbiology Review
5/10/2013NDA: 022225
Drug Product Name
Proprietary:
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How to fill out spritam tablets - fda
How to fill out spritam tablets - fda
01
Start by preparing a clean and dry surface.
02
Place the Spritam tablet on the surface.
03
Take a glass of water and hold it in one hand.
04
Use the other hand to pick up the tablet and place it on your tongue.
05
Take a sip of water and swallow the tablet.
06
If needed, you can drink more water to ensure the tablet is fully swallowed.
07
Store the remaining tablets in a cool and dry place, away from moisture and heat.
Who needs spritam tablets - fda?
01
Spritan tablets are typically prescribed to individuals who suffer from epilepsy or seizures.
02
These tablets are also used as a treatment for certain types of seizures in adults and children.
03
The prescription and use of Spritam tablets should be determined by a healthcare professional.
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What is spritam tablets - fda?
Spritam tablets is a medication approved by the FDA for the treatment of epilepsy.
Who is required to file spritam tablets - fda?
The manufacturer of spritam tablets is required to file with the FDA for approval.
How to fill out spritam tablets - fda?
To fill out the FDA application for spritam tablets, the manufacturer must provide detailed information about the medication's ingredients, efficacy, and safety profile.
What is the purpose of spritam tablets - fda?
The purpose of filing spritam tablets with the FDA is to gain approval for its sale and distribution in the United States.
What information must be reported on spritam tablets - fda?
The manufacturer must report information on the ingredients, manufacturing process, clinical trials, and potential side effects of spritam tablets.
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