The primary requirement for a drug to be eligible to get approval based on an ANDA is that the drug has to have the same active ingredient or ingredients, but route of administration, dosage form, strength, and conditions of use as a reference listed drug may be different.
False. The primary requirement for a drug to be eligible to get approval based on an ANDA is that the drug has to have the same active ingredient or ingredients, route of administration, dosage form, strength, and conditions of use as a drug that FDA has already approved, referred to as the "reference listed drug," or (RLD).