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What is the difference between FDA Form 3542 and 3542a?
Use this Form FDA 3542 only if the NDA holder is submitting information on a patent that claims an approved drug or an approved method of using the drug. If the NDA holder is submitting patent information with an original NDA, an amendment, or a supplement prior to approval, you must use Form FDA 3542a.
What is Form 3542?
Form FDA 3542 Used to submit patent information on a patent that. claims the following: An approved drug. An approved method of using the drug. Submitted upon approval of an NDA or supplement.
What is FDA Form 3542?
Use this Form FDA 3542 only if the NDA holder is submitting information on a patent that claims an approved drug or an approved method of using the drug. If the NDA holder is submitting patent information with an original NDA, an amendment, or a supplement prior to approval, you must use Form FDA 3542a.
What is the difference between 3542 and 3542a?
Form 3542a should be used when submitting patent information with original NDA submissions, NDA amendments and NDA supplements prior to approval. Form 3542 should be used after NDA or supplement approval.
What is FDA Form 3794?
We have developed Form FDA 3794, the Generic Drug User Fee Cover Sheet, available at industry/fda-user-fee-programs which requests the minimum necessary information from generic drug applicants to account for and track user fees and to determine the amount of the fee required.
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