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  • (sodium Oxybate) Oral Solution - Fda

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REMS DOCUMENT Initial REMS approval: 02/2015 NDA 21196 (SODIUM OXYBATE) ORAL SOLUTION Jazz Pharmaceuticals, Inc.3180 Porter DrivePalo Alto, CA 94304Phone: 6504963777Email: regulatory jazzpharma.comRISK.

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How to use or fill out the (SODIUM OXYBATE) ORAL SOLUTION - FDA online

This guide provides a step-by-step process to complete the (SODIUM OXYBATE) ORAL SOLUTION form online. The aim is to ensure a clear understanding of each section and facilitate a smooth submission experience.

Follow the steps to fill out the (SODIUM OXYBATE) ORAL SOLUTION form with ease.

  1. Press the ‘Get Form’ button to access the form online.
  2. Complete the prescriber information section, including all marked required fields such as name, DEA number, and contact details.
  3. Fill in the patient information. Ensure the patient’s name, date of birth, and contact details are accurately recorded.
  4. Review the counseling attestation and ensure all required checks are marked, confirming that the patient has been counseled on risks and safe use.
  5. When entering the dosage information, provide the total prescribed amount and specify any titration details per your practice guidelines.
  6. Include any additional notes or instructions relevant to the prescription as necessary.
  7. Finally, review all sections for completeness before submitting the form.
  8. After completion, you can choose to save changes, download the form, print it, or share it with stakeholders as needed.

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(sodium oxybate) Information | FDA
Jan 25, 2017 — (sodium oxybate) Oral Solution is a prescription medicine approved by the...
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GHB's Path to Legitimacy - Harvard DASH
[17] The drug, marketed under the trade name , is sodium oxybate, a sodium ... [22]...
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gamma-Hydroxybutyric acid - Wikipedia
gamma-Hydroxybutyric acid or γ-Hydroxybutyric acid (GHB), also known as 4-hydroxybutanoic...
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A generic version of was approved January 17, 2017 but it has since been discontinued. There is currently no therapeutically equivalent version of available in the United States.

is not available at your local pharmacy. As part of the XYWAV and REMS, is available only through a Certified Pharmacy. It is the only pharmacy in the United States permitted to fill the prescription and send directly to patients.

Sodium oxybate is the sodium salt of -hydroxybutyric acid (GHB).

The Coupon Program is not prescription drug coverage or insurance. Patients cannot seek reimbursement from health insurance or any third party for any part of the benefit received by the patient through the Coupon Program.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232