Date of Submission
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.)
1. What model labeling is your product labeling based upon?
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 Evaluations (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?
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. Are the proposed inactive ingredients consistent with the inactive ingredients of the Reference Listed Drug (RLD)?
8. Who manufactures the drug product?
9. Who distributes the drug product?
10. How does your product description in the insert labeling compare with the product description in the Finished Product Specifications?
11. How does your product description compare with the product description of the RLD?
12. How does your product’s dimensions compare with the dimensions of the RLD suppository?
13. How does your proposed container/closure system differ from the container/ closure system of the RLD?
14. What child-resistant feature(s) are utilized for each of your proposed packaging configurations?
15. Is the proposed product intended for Over-the-Counter use? If so, describe how the conditions of 21 CFR 211.132 are met; comment regarding 21 CFR 132.132(b)(1), (b)(2), and (c).
16. How do your package configurations compare with the package configurations of the RLD? (e.g., use of unit dose cartons).
17. How does your storage temperature statement compare with the storage temperature statement of the RLD and USP (if applicable)? Please justify the differences.
18. How do your dispensing recommendation statements compare with the dispensing recommendation statements of the RLD?
SPL Data Elements
19. Are the SPL Data Elements consistent with the information provided in your application and in the insert labeling?
20. Are the FDA Toll Free Number, MedWatch web address and manufacturer’s phone number present in the labeling?
21. Is a Risk Evaluation and Mitigation Strategy (REMS) required for the proposed product?
22. Is a non-REMS risk mitigation strategy in place for the RLD, e.g., a Riskmap?
23. Is your proposed product subject to any petitions?
24. 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.
1. Is your product an Over-the-Counter medication?
2. If so, explain how it meets content and format regulations set forth in the regulations?
3. Have you included a legend with your submission?
4. How does your product meet tamper-resistant requirements set forth in 21 CFR 211.132?
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?
1. Is your drug product registered?
2. Does your product meet the conditions of 21 CFR 207.35(b)(3)(i), regarding the proper placement of the NDC code on labeling?
1. Does a lot number, control number, or batch number appear on the labels as described in 21 CFR 201.18?
1. How are the conditions of 21 CFR 201.25 met?
Formatting, wording preferences
1. Do your labels and labeling meet formatting requirements set forth in the regulations, e.g., font size?
Instructions for Use
1. How do the instructions for use differ from those of the Reference Listed Drug (RLD)?
2. If the instructions differ from the RLD, have similar instructions been approved for another of your approved drug products?
1. How does the Medication Guide for this product differ from that approved for the RLD?
2. How will the Medication Guide be provided with the product and how many will accompany each package size?
3. Are the conditions of 21 CFR 208.20 met with regard to proper Medication Guide formatting?
4. Do the proposed container labels direct the health care provider to dispense the Medication Guide as required by 21 CFR 208.24(d)?
5. 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
1. How does the Patient Information Leaflet for this product differ from that approved for the RLD?
2. How will the Patient Information Leaflet be provided with the product and how many will accompany each package size?
3. 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.
1. Are your product strengths sufficiently differentiated to reduce chance of medication errors?
2. 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?
3. Is there sufficient contrast between the expression of strength and background color on container labels and carton labeling?
4. Are you proposing a product with Tall Man Lettering?