Questions+Under+Review+at+FDA

[Question to FDA June 24, 2009]

Subject:
One product, marketed under two names and prescribing information. How to handle with SPL?

Question:
Sponsor markets Brand Product A under logo-1 with NDC 0173-0001-01. Sponsor also markets Brand Product A under Logo-2 with NDC 0173-0001-02 Currently the two NDCs are on separate PI's and therefore separate SPL files. Can sponsor submit two SPL files with the name Brand Product A, the same NDC product code successfully? Will the files, with different SetID's fail validation? (I'm guessing the second submission will fail?) If sponsor changes the NDC product codes for one of the files (NDC 0173-0001-02 becomes NDC 0173-0002-02), but keep the same Brand Product A Name and different SetID's will it fail? In other words, does the system force all items of the same strength and Brand name to be in a single spl file?

Answer:
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Reference(s) :
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[Question to FDA July, 2009]

Subject:
Packaging containing multiple chewable tablet of same strength. Different colors, possibly different flavors

Question:
Currently, SPL COLOR allows multiple colors to be chosen if they apply to a single capsule or other oral dose form.

How should color be represented in SPL for an OTC product with 4 different colored tablets (orange tablets, green tablets, red tablets, and pink tablets)? Would the FDA include another term in the list of colors that covered this particular situation?

Answer:
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Reference(s) :
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