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This document serves as a review of the labeling revisions submitted by Purdue Pharma for the reformulated OxyContin product, focusing on compliance with health and safety regulations and addressing
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How to fill out nda 22-272 oxycontin oxycodone
How to fill out NDA 22-272 OxyContin (Oxycodone Hydrochloride Controlled-Release)
01
Download NDA 22-272 OxyContin (Oxycodone Hydrochloride Controlled-Release) from the FDA website.
02
Read the instructions provided with the NDA carefully.
03
Fill out the initial sections, including sponsor information and drug details.
04
Provide clinical and non-clinical data that supports the drug's safety and efficacy.
05
Include proposed labeling information and packaging details.
06
Attach any relevant studies and data to support the application.
07
Review the entire document for completeness and accuracy.
08
Submit the NDA to the FDA electronically through the appropriate submission portal.
Who needs NDA 22-272 OxyContin (Oxycodone Hydrochloride Controlled-Release)?
01
Pharmaceutical companies looking to market OxyContin.
02
Healthcare providers involved in prescribing controlled-release Oxycodone.
03
Patients seeking information on the availability of OxyContin.
04
Regulatory bodies monitoring the approval of controlled substances.
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People Also Ask about
What is oxycodone hydrochloride?
Description. Oxycodone is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. It belongs to the group of medicines called opioid analgesics (pain medicines). Oxycodone acts on the central nervous system (CNS) to relieve pain.
Is oxycodone stronger than hydrochloride?
One key difference is that oxycodone is more potent than hydrocodone. This means that it takes less oxycodone to produce the same effects as hydrocodone. Oxycodone is also more likely to be abused than hydrocodone because it produces stronger effects. This also means that oxycodone has a higher risk of overdose.
What is the new name for Percocet?
The generic name for Percocet is oxycodone acetaminophen.
Is oxycodone hydrochloride the same as Percocet?
Percocet is a combination medication that includes both oxycodone and acetaminophen. The addition of acetaminophen enhances the pain-relieving effects of oxycodone. This combination makes Percocet effective for treating moderate to severe pain, often used for short-term pain management.
What is the other name for oxycodone hydrochloride 5mg?
Common brands of oxycodone include Endone, OxyContin and OxyNorm.
Is oxycodone hydrochloride like a Percocet?
Both Percocet and oxycodone-CR products relieve pain, but while Percocet gives relief for about five hours, the effects of oxycodone-CR last for about 12 hours, when taken as prescribed. Percocet contains five milligrams of oxycodone, which is all released when the pill is taken.
What is oxycodone HCl controlled-release?
Oxycodone HCl Controlled-Release Tablets are designed to provide controlled delivery of oxycodone over 12 hours. Breaking, chewing or crushing Oxycodone HCl Controlled-Release Tablets eliminates the controlled delivery mechanism and results in the rapid release and absorption of a potentially fatal dose of oxycodone.
Is OxyContin still sold in the United States?
OxyContin, a trade name for the narcotic oxycodone hydrochloride, is a painkiller available in the United States only by prescription. OxyContin is legitimately prescribed for relief of moderate to severe pain resulting from injuries, bursitis, neuralgia, arthritis, and cancer.
What is the trade name for oxycodone hydrochloride?
OxyContin, a trade name for the narcotic oxycodone hydrochloride, is a painkiller available in the United States only by prescription.
What is the difference between OxyContin and oxycodone hydrochloride?
The differences are simply that oxycodone is an opioid substance that is the main ingredient in a number of pain medications (including OxyContin) and that OxyContin is the time-release version of oxycodone.
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What is NDA 22-272 OxyContin (Oxycodone Hydrochloride Controlled-Release)?
NDA 22-272 refers to the New Drug Application submitted for OxyContin, which contains Oxycodone Hydrochloride in a controlled-release formulation. It is used for the management of pain severe enough to require an opioid analgesic.
Who is required to file NDA 22-272 OxyContin (Oxycodone Hydrochloride Controlled-Release)?
The manufacturer or sponsor of the drug is required to file NDA 22-272 for OxyContin. This includes pharmaceutical companies that seek approval for new drugs from the FDA.
How to fill out NDA 22-272 OxyContin (Oxycodone Hydrochloride Controlled-Release)?
To fill out NDA 22-272, the applicant must submit detailed information including clinical study data, manufacturing processes, labeling, and proposed usage. The application must comply with FDA guidelines and include evidence of safety and efficacy.
What is the purpose of NDA 22-272 OxyContin (Oxycodone Hydrochloride Controlled-Release)?
The purpose of NDA 22-272 is to gain FDA approval for OxyContin as a safe and effective medication for patients suffering from severe pain, ensuring community health through regulated medicinal use.
What information must be reported on NDA 22-272 OxyContin (Oxycodone Hydrochloride Controlled-Release)?
The NDA must include information on the drug's pharmacokinetics, pharmacodynamics, clinical trial results, proposed labeling, manufacturing details, and risk assessments, along with any relevant safety data.
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