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U.S. Department of Health and Human Services

Drugs

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Tablet Dosage Form Questions

Introduction:

ANDA Number
Date of Submission
Applicant’s Name
Established Name of the Drug Product
Proprietary Name of the Drug Product (include date proposed)
Labeling Submissions (proposed labeling pieces, e.g., container, carton, FPL, SPL, etc.)
 
QbR Questions:
 
Model Labeling 
1.   What model labeling(s) is your product labeling based upon?
 
USP Monograph 
2.   Is there a USP Drug Product Monograph, and if so, does your product’s labeling meet the USP requirements?
 
Patents and Exclusivities 
3.   What are the currently approved patents and exclusivities for the reference listed drug as listed in the Approved Drug Products with Therapeutic Equivalence Evaluation (Orange Book), and what impact do they have on the labeling submitted?
 
4.   What are the certifications and labeling impacts for each patent and exclusivity?
 
Inactive Ingredients 
5.   Is the listing of inactive ingredients in the DESCRIPTION section of the package insert consistent with the listing of inactive ingredients found in the statement of components and composition and SPL data elements?
 
6.   Do any of your inactive ingredients require special labeling statements or have regulatory requirements?
 
Manufacturing Facility 
7.   Who manufactures the drug product?
 
8.   Who distributes the drug product?
 
Product Description 
9.   How does your product description in the insert labeling compare with the product description in the Finished Product Specifications?
 
10.  How does your product description compare with the product description of the RLD?
 
11.  Is your product’s scoring configuration in conformance with OGD’s policy?
 
12.  How does your product’s dimensions compare with the dimensions of the RLD tablet?
 
13.  How are the conditions of 21 CFR 206 (Imprinting of Solid Oral Dosage Form) met?
 
14.  Is the RLD tablet strength linked to or generally recognized by tablet color? 
 
Container/Closure System 
15.  How does your proposed container/closure system differ from the container/closure system of the RLD?
 
16.  What child-resistant feature(s) are utilized for each of your proposed packaging configurations?
 
Product Line 
17.  How do your packaging configurations compare with the packaging configurations of the RLD? (e.g., use of unit dose cartons).
 
Storage Conditions 
18.  How does your storage temperature statement compare with the storage temperature statement of the RLD and USP (if applicable)? Please justify the differences.
 
19.  Is this product light sensitive? If so, do the storage recommendations and/or special packaging address light sensitivity?
 
Dispensing Recommendations 
20.  How do your dispensing recommendation statements compare with the dispensing recommendation statements of the RLD?
 
SPL Data Elements 
21.  Are the SPL Data Elements consistent with information provided in your application and in the insert labeling?
 
Medwatch 
22.  Are the FDA Toll Free Number, MedWatch web address and manufacturer’s phone number present in the labeling?
 
REMS
23.  Is a Risk Evaluation and Mitigation Strategy (REMS) required for the proposed product?
 
24.  Is a non-REMS risk mitigation strategy in place for the RLD, e.g., a Riskmap?
 
Petitions 
25.  Is your proposed product subject to any petitions?
 
Pregnancy Registry
26.   Does RLD labeling reference a pregnancy registry and if so, do you also propose a pregnancy registry. Please provide your rationale for not including a registry that appears in the labeling of the RLD. 
 
Additional Questions:
 
Controlled Substance Labeling 
1.   Is your product a controlled substance? If yes, does labeling meet regulatory requirements for location and size of symbol?
 
2.   Does the proposed packaging meet requirements for tamper-evident sealing?
 
NDC Codes 
3.   Is your drug product registered?
 
4.   Does your product meet the conditions of 21 CFR 207.35(b)(3)(i), regarding the proper placement of the NDC code on labeling?
 
Lot Numbers
5.   Does a lot number, control number, or batch number appear on the label as described in 21 CFR 201.18?
  
Bar Coding
6.   How are the conditions of 21 CFR 201.25 (Bar Code Label Requirements) met?
 
Formatting, wording preferences
7.   Do your labels and labeling meet formatting requirements set forth in the regulations? (e.g., font size).
 
Medication Guides 
8.   How does the Medication Guide for this product differ from that approved for the RLD?
 
9.   How will the Medication Guide be provided with the product and how many will accompany each package size?
 
10. Are the conditions of 21 CFR 208.20 (Content and Format of a Medication Guide) met with regard to proper Medication Guide formatting?
 
11. Do the proposed container labels direct the health care provider to dispense the Medication Guide as required by 21 CFR 208.24(d) (Distributing and Dispensing a Medication Guide)?
 
12. Have requirements for providing a toll-free number for reporting adverse events been met by including the following text with the Medication Guide?
 
Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA 1088.
 
Patient Information Leaflet 
13. How does the Patient Information Leaflet for this product differ from that approved for the RLD?
 
14. How will the Patient Information Leaflet be provided with the product and how many will accompany each package size?
 
15. Have requirements for providing a toll-free number for reporting adverse events been met by including the following text with the patient information?
 
Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA 1088.
  
Differentiation
16. Are your product strengths sufficiently differentiated to reduce chance of medication errors?
 
17. Where there is a possibility the products will be stored in close proximity, is there adequate differentiation between your proposed product and your approved products? 
 
18. Is there sufficient contrast between the expression of strength and background color on container labels and carton labeling? 
 
19. Are you proposing a product with Tall Man Lettering?
 
  

Product-Specific LABELING QUESTIONS

 
Extended-Release Tablets
1.   What warnings and information are present in the labeling about breaking or crushing the tablet?

2.   How does the kinetic data of your product compare with that of the RLD?

3.   How does your product’s release mechanism compare with the RLD’s release mechanism?

4.   Does the RLD labeling have any labeling statements related to the release or design of the tablet? If so, how does your proposed statements compare to the RLD?

 
Chewable Tablets
1.   How does the labeling of the RLD and your proposed product identify this as a chewable tablet?

2.   Does the instructions for use differ from those of the Reference Listed Drug (RLD)? If so, have similar instructions been approved for another of your approved drug products?

 
Orally Disintegrating Tablets
1.   How does your disintegration time statement compare with the disintegration time statement of the RLD and USP (if applicable)?  
 

Film Coating
1.   Does the RLD tablet have a film coating? If so, what are your plans regarding film coating the tablet?