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Form Approved: OMB No. 0910-0001, Expiration Date: March 31, 2021; see PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
1. Date Submitted
22.04.2019
2. Label Review Number (Biologics)
12312A1BCD
3. NDA/ANDA/AADA or BLA/PMA
Type: Some type
Number: XYZ1231
Single product
Multiple product
For multiple products, submit completed form and specimen of advertising/promotional materials to one application of choice, and attach separate sheet addressing items 3-5 for remainder of products. Refer to No. 3 on instruction sheet.
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