Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Drug Master Files (DMFs)

Drug Master Files (DMFs)

                        List of Drug Master Files (DMFs)
          Types of Drug Master Files (DMFs)
          Drug Master File (DMF) Submission Resources
          Drug Master File (DMF) Templates
          Drug Master File (DMF) Related Information Home
          Drugs
          Development & Approval Process | Drugs
          Forms & Submission Requirements
          Drug Master Files (DMFs)
          FDA IND, NDA, ANDA, or Drug Master File BindersDrug Master Files (DMFs) FDA IND, NDA, ANDA, or Drug Master File Binders
  
  	
    Share
    Post
    Linkedin

    Email
    PrintREQUIREDSPECIFICATIONS FOR FDA’s
IND, NDA, ANDA, DRUG MASTER FILE BINDERS

Binders (covers) can be ordered on line from the U.S. Government Printing Office (GPO) Web site: http://bookstore.gpo.gov/  by searching for the appropriate form or by calling 202-512-1800 to speak with a GPO customer service representative.

If you have any questions or need additional information regarding the use of the binders , please contact FDA via druginfo@fda.hhs.gov.

Binders that are not ordered from the GPO must meet the following requirements:

POLYETHYLENE BINDERS-

Front (flat size) - 248 x 292mm (9-3/4 x 11-1/2")
Back (flat size) - 248 x 305mm (9-3/4 x 12") (size includes 13 mm (1/2") lip at top)
Must be high impact linear plastic (matte finish or similar) - Must be able to withstand temperatures up to 150 degrees - Material should have a surface smooth enough to allow printing with a complete bonding of ink to the surface after a minimum of one hour drying time - Should be free from streaks, blisters, scratches and mottling -
Binder weight MUST be .023-.025 gauge - Ink color MUST be BLACK -
Polyethylene Binders include -

FDA Form 2626 - Blue - NDA ARCHIVAL BINDER
	FDA Form 2675 - Red - IND ARCHIVAL BINDER
	FDA Form 3316 - Red - DRUG MASTER FILE BINDER
	FDA Form 3316a - Blue - DRUG MASTER FILE  ARCHIVAL BINDERPAPER BINDERS-

Front (flat size) - 267 x 292mm (10-1/2 x 11-1/2")
Back (flat size) - 267 x 305mm (10-1/2 x 12") (size includes 13mm (1/2") lip at top)
Binder MUST be of 11-point plate rope stock of extra heavy weight - Ink color MUST be BLACK - Maroon binder ink color MUST be WHITE -
Paper Binders include -

FDA Form 2626a - Red - NDA CHEMISTRY BINDER
	FDA Form 2626b - Yellow - NDA PHARMACOLOGY BINDER
	FDA Form 2626c - Orange - NDA PHARMACOKINETIC BINDER
	FDA Form 2626d - White - NDA MICROBIOLOGY BINDER
	FDA Form 2626e - Tan - NDA CLINICAL DATA BINDER
	FDA Form 2626f - Green - NDA STATISTICS BINDER
	FDA Form 2626h - Maroon - NDA FIELD SUBMISSION CHEMISTRY BINDER
	FDA Form 2675a - Green - IND CHEMISTRY BINDER
	FDA Form 2675b - Orange - IND MICROBIOLOGY BINDERPRINTING - Required on front folder in a clear, sharp, permanent-type print in **BLACK** ink - Permanent adhesive labels may be used in a clear, sharp print - Printing must withstand a "Scotch Tape Test" which consists of pressing a strip of "Scotch" tape firmly on the printed area and removing - There should be NO transfer of the printed area on the tape -
BINDING - POLYETHYLENE binders (front and back) MUST contain an internal (HIDDEN) hinge formed in the material by heat and pressure - Hinge should extend along the entire left-hand binding edge of the binder and be of a depth to provide a clean straight fold free from wrinkle when created or folded on the hinge - Hinge holes should be reinforced with metal eyelets and suitable for accommodating an ACCO-type fastener allowing for expansion - Outside binder surfaces MUST be smooth with NO exposed hinges or fastener -
PAPER binders (front and back) MUST have 2 hinge holes scored along the entire left-hand binding edge and must be of a depth to provide a clean straight fold free from wrinkle when creased or folded on the score - Hinge holes should be reinforced and suitable for accommodating an ACCO-type fastener allowing for expansion -
Round corner the inside edge of tab on back folder and outside edges of the front and back folders on polyethylene and paper binders -
Finished margins MUST conform with binder sizes indicated above -
Below is a cover sample for FDA Form 2626, 2626a thru h - NDA Applications
Below is a cover sample for FDA Form 2675, 2675a and b - IND Appications
Below is a cover sample for FDA Form 3316, 3316a - Drug Master Files



**SPECIFICATIONS Page 2**



**SAMPLE COVER - FORM FDA 2626**(series a-h)



NOTE: Sample is SMALLER in print (FONT) size than actual cover. Printing MUST match lay-out of previously submitted section binders.

**VOLUME __________________**





**NEW DRUG APPLICATION**



**NDA No. _________**





**NAME OF APPLICANT**





**NAME OF NEW DRUG**





**SECTION NAME (* see below)**



**This submission: VOL.______OF______VOLS.**



**--------------------**



Listed below are FDA New Drug Application (NDA) / Abbreviated New Drug Application (ANDA) binders identical to sample above. Section cover name is **ONLY** difference.

*** FORM #**
			**COLOR**
			**INK**
			< strong="">SECTION COVER NAME2626
			Blue
			Black
			ARCHIVAL COPY2626a
			Red
			Black
			NDA CHEMISTRY2626b
			Yellow
			Black
			NDA PHARMACOLOGY2626c
			Orange
			Black
			NDA PHARMACOKINETIC2626d
			White
			Black
			NDA MICROBIOLOGY2626e
			Tan
			Black
			NDA CLINICAL DATA2626f
			Green
			Black
			NDA STATISTICS2626h
			Maroon
			White
			NDA FIELD SUBMISSION CHEMISTRY

**SPECIFICATIONS Page 3**



**SAMPLE COVER - FORM FDA 2675**(series a-b)



Note: Sample is smaller in print (FONT) size than actual cover. Printing MUST match lay-out of previously submitted section binders.



**VOLUME __________________**





**NOTICE OF CLAIMED**



**INVESTIGATIONAL**



**EXEMPTION FOR A**



**NEW DRUG**





**IND. NO.__________**





**SPONSOR**





**NAME OF DRUG (* see below)**





**This submission: VOL._____OF______VOLS.**



**--------------------**



Listed below are FDA Investigational New Drug (IND) binders identical to sample above. Section cover name is **ONLY** difference.

*** FORM #**
			**COLOR**
			**INK**
			**COVER DRUG NAME**2675
			Red
			Black
			IND NAME OF DRUG2675a
			Green
			Black
			IND NAME OF DRUG2675b
			Orange
			Black
			IND NAME OF DRUG





**SPECIFICATIONS Page 4**



**SAMPLE COVER - FDA FORM 3316**



NOTE: Sample is SMALLER in print (FONT) size than actual****cover. Printing MUST match lay-out of previously submitted section binders.



**VOLUME __________________**





**DRUG MASTER FILE**



**NO. ________**





**NAME OF APPLICANT**

**(* see below)**





**TYPE:**





**This submission: VOL.______OF______VOLS.**



**--------------------**



Listed below are FDA Drug Master File (DMF) binders identical to sample above. File # and Type will be **ONLY** difference.

*** FORM #**
			**COLOR**
			**INK**
			**COVER NAME**3316
			Red
			Black
			Drug Master File3316a
			Blue
			Black
			Drug Master File

                                                                                  Content current as of:
      09/23/2016Drug Master Files (DMFs)

          
                        List of Drug Master Files (DMFs)
          Types of Drug Master Files (DMFs)
          Drug Master File (DMF) Submission Resources
          Drug Master File (DMF) Templates
          Drug Master File (DMF) Related Information
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop