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Inhalation Dosage Form Questions


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?
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?
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 the RLD inhalation strength linked to or generally recognized by  color? 
Container/Closure System 
12.   How does your proposed container/closure system differ from the container/closure system of the RLD?
13.   What child-resistant feature(s) are utilized for each of your proposed packaging configurations?
Product Line 
14.   How do your packaging configurations compare with the packaging configurations of the RLD? (e.g., use of unit dose cartons).
Storage Conditions  
15.   How does your storage temperature statement compare with the storage temperature statement of the RLD and USP (if applicable)? Please justify the differences.
16.   Is this product light sensitive? If so, do the storage recommendations and/or special packaging address light sensitivity?
Dispensing Recommendations 
17.   How do your dispensing recommendation statements compare with the dispensing recommendation statements of the RLD?
SPL Data Elements 
18.   Are the SPL Data Elements consistent with information provided in your application and in the insert labeling?
19.   Are the FDA Toll Free Number, MedWatch web address and manufacturer’s phone number present in the labeling?
20.   Is a Risk Evaluation and Mitigation Strategy (REMS) required for the proposed product?
21.   Is a non-REMS risk mitigation strategy in place for the RLD, e.g., a Riskmap?
22.   Is your proposed product subject to any petitions?
Pregnancy Registry 
23.    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.
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?
  • Inhalations
  1. Are the active and inactives q1/q2 the same as the reference product.
  2. Does the propellant for your product require a warning statement in accordance with 21 CFR 201.320(a)(1) and (a)(2). 
  • Unit dose nebules inhalations
  1. Is the word "sterile" on the container and carton?
  2. Are the terms "Not for injection" on the container?
  3. Are pouches provided to protect the product from light?
  • Oral inhalations Solution 
Are all appropriate strength designations used? For example, is the declaration of strength expressed both in % (mg/v, v/v) and mg/v somewhere on the labels or labeling.
  • Nasal inhalations
Is the word "Nasal" clearly denoted on the label? 
  • Use of the terms Nasal Spray VS Nasal Solution
Is the correct terminology used "Spray" vs.  "Solution"- depending on the container and deliver system? (Pre-assembled canisters are typically sprays while bottles that required assembly are typically solutions.)
  • Dry powder inhaler
  1. Are the containers similar in color to the reference product?
  2. Are there no differences in the way the counter operates (count down)?
  3. Are there differences from the RLD in the internal mechanism operation?
  4. Are the steps to operate the device, for the customer, the same as the reference listed drug?

Page Last Updated: 09/30/2016
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