| Comment Record |
|
Commentor |
Ms. Leah Ripper |
Date/Time |
2002-04-04 17:28:24 |
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Organization |
FDA/CDER |
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Category |
Other |
| Comments for FDA General |
| Questions |
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1. General Comments
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Line 166 speaks of approved labeling of regulated products. Which, if any, of the following would fall into this category:
1. The product is only marketed as a grandfathered (no NDA) drug product.
2. The product is marketed as a DESI-related product (no NDA).
3. The NDA was approved pre-l962 and the DESI review has not been completed for it (labeling includes the possibly effective box), e.g., Midrin.
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