ProductDataTemplate FDA Approval Type

Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) - IRA

ProductDataTemplate FDA Approval Type

OMB: 0938-0921

Document [pdf]
Download: pdf | pdf
FDA Approval Type
510(K)
ANDA
BLA
BLA 351(k)
HCT/P
NDA-505(b)(1)
NDA-505(b)(2)
OTHER
PMA

Valid For NDC

Valid For Alternate ID
Yes

Yes
Yes
Yes
Yes
Yes
Yes
Yes

Yes
Yes


File Typeapplication/pdf
File TitleFDA Approval Type
AuthorMichelle Berman
File Modified2024-01-24
File Created2024-01-24

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