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Hello All,
How many submission batches would be needed for an ANDA submission for a product with multiple strength and flavors.
For example: If a product has two strengths X and Y and 3 flavors A, B & C.
Would it be required to make:
1) 3 batches of strength X with flavor A
2) 3 batches of strength Y with Flavor A
3) 3 batches of strength X with flavor B
4) 3 batches of strength Y with Flavor B
5) 3 batches of strength X with flavor C
6) 3 batches of strength Y with Flavor C
Please note that both strengths X and Y are proportionally similar.
Thank you.