Get the free nda 021529/s-018 supplement approval - accessdata.fda.gov
Show details
CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 021529Orig1s018 Trade Name:NEXPLANONGeneric or Proper Name: implantSponsor:Organon USA Inc., a subsidiary of Merck & Co., Inc.Approval Date:April 22, 2019Indication: is a progestin indicated for use by women to prevent pregnancy.CENTER FOR DRUG EVALUATION AND RESEARCH021529Orig1s018 CONTENTSReviews / Information Included in this NDA Review. Approval Letter Other Action Letters Labeling REMS Summary
We are not affiliated with any brand or entity on this form
Get, Create, Make and Sign nda 021529s-018 supplement approval
Edit your nda 021529s-018 supplement approval form online
Type text, complete fillable fields, insert images, highlight or blackout data for discretion, add comments, and more.
Add your legally-binding signature
Draw or type your signature, upload a signature image, or capture it with your digital camera.
Share your form instantly
Email, fax, or share your nda 021529s-018 supplement approval form via URL. You can also download, print, or export forms to your preferred cloud storage service.
Editing nda 021529s-018 supplement approval online
To use our professional PDF editor, follow these steps:
1
Check your account. In case you're new, it's time to start your free trial.
2
Simply add a document. Select Add New from your Dashboard and import a file into the system by uploading it from your device or importing it via the cloud, online, or internal mail. Then click Begin editing.
3
Edit nda 021529s-018 supplement approval. Rearrange and rotate pages, add and edit text, and use additional tools. To save changes and return to your Dashboard, click Done. The Documents tab allows you to merge, divide, lock, or unlock files.
4
Get your file. Select the name of your file in the docs list and choose your preferred exporting method. You can download it as a PDF, save it in another format, send it by email, or transfer it to the cloud.
The use of pdfFiller makes dealing with documents straightforward. Now is the time to try it!
Uncompromising security for your PDF editing and eSignature needs
Your private information is safe with pdfFiller. We employ end-to-end encryption, secure cloud storage, and advanced access control to protect your documents and maintain regulatory compliance.
How to fill out nda 021529s-018 supplement approval
How to fill out nda 021529s-018 supplement approval
01
Obtain the nda 021529s-018 supplement approval form from the regulatory authority's website or relevant agency.
02
Carefully read the instructions and guidelines provided with the form to understand the requirements.
03
Fill in the applicant's information, including name, address, and contact details.
04
Provide the required details about the drug or supplement being submitted, including its name, proposed indications, and other pertinent information.
05
Include any supporting data or documentation as outlined in the instructions, such as clinical trial results or safety data.
06
Review the completed form for accuracy and completeness, ensuring all sections are filled out as required.
07
Sign and date the form where indicated to certify the submission.
08
Submit the completed form along with any required fees to the appropriate regulatory authority.
Who needs nda 021529s-018 supplement approval?
01
Pharmaceutical companies seeking to market a new drug or supplement.
02
Research institutions conducting clinical trials involving new therapies.
03
Any organization or individual involved in the development and commercialization of drug products.
Fill
form
: Try Risk Free
For pdfFiller’s FAQs
Below is a list of the most common customer questions. If you can’t find an answer to your question, please don’t hesitate to reach out to us.
Where do I find nda 021529s-018 supplement approval?
The pdfFiller premium subscription gives you access to a large library of fillable forms (over 25 million fillable templates) that you can download, fill out, print, and sign. In the library, you'll have no problem discovering state-specific nda 021529s-018 supplement approval and other forms. Find the template you want and tweak it with powerful editing tools.
How can I edit nda 021529s-018 supplement approval on a smartphone?
You can do so easily with pdfFiller’s applications for iOS and Android devices, which can be found at the Apple Store and Google Play Store, respectively. Alternatively, you can get the app on our web page: https://edit-pdf-ios-android.pdffiller.com/. Install the application, log in, and start editing nda 021529s-018 supplement approval right away.
How do I edit nda 021529s-018 supplement approval on an Android device?
The pdfFiller app for Android allows you to edit PDF files like nda 021529s-018 supplement approval. Mobile document editing, signing, and sending. Install the app to ease document management anywhere.
What is nda 021529s-018 supplement approval?
NDA 021529s-018 supplement approval refers to a specific supplemental application submitted to the FDA concerning an existing New Drug Application (NDA) that may involve changes to the product, including indications, formulation, or labeling.
Who is required to file nda 021529s-018 supplement approval?
The holder of the NDA, typically a pharmaceutical company, is required to file NDA 021529s-018 supplement approval when they seek to implement changes that require FDA review and approval before being marketed.
How to fill out nda 021529s-018 supplement approval?
To fill out NDA 021529s-018 supplement approval, the applicant must complete the required FDA forms, provide detailed information about the proposed changes, submit relevant data, and ensure all required documentation is included according to the FDA's guidelines.
What is the purpose of nda 021529s-018 supplement approval?
The purpose of NDA 021529s-018 supplement approval is to evaluate and approve modifications to the existing drug's application, ensuring that any new information or changes meet safety, efficacy, and regulatory compliance standards.
What information must be reported on nda 021529s-018 supplement approval?
Information that must be reported includes details of the proposed changes, relevant clinical and non-clinical data supporting the application, labeling changes, manufacturing information, and any other information as specified by FDA requirements.
Fill out your nda 021529s-018 supplement approval online with pdfFiller!
pdfFiller is an end-to-end solution for managing, creating, and editing documents and forms in the cloud. Save time and hassle by preparing your tax forms online.
Nda 021529s-018 Supplement Approval is not the form you're looking for?Search for another form here.
If you believe that this page should be taken down, please follow our DMCA take down process
here
.
This form may include fields for payment information. Data entered in these fields is not covered by PCI DSS compliance.
