What Are The Examples Of Changes To Approved Drug Products For Which

1.	What Are The Examples Of Changes To Approved Drug Products For Which 505(b)(2) Application Should Be Submitted ?
Answer» Change in DOSAGE form. Change in strength. Change in ROUTE of administration. Substitution of an ACTIVE ingredient in a formulation product. Change in formulation. Change in dosing regimen. Change in active ingredient. New combination Product. New indication. Change from prescription indication to OTC indication. Naturally derived or recombinant active ingredient. Bioinequivalence.

What Are The Examples Of Changes To Approved Drug Products For Which 505(b)(2) Application Should Be Submitted ?

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