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2022 Biological Approvals
… ines-blood-biologics/development-approval-process-cber/2022-biological-approvals … The Center for Biologics Evaluation and Research … new dosage formulations and improved safety). 2022 Biological License Application Approvals 2022 Biological …
2024 Biological Approvals
… ines-blood-biologics/development-approval-process-cber/2024-biological-approvals … The Center for Biologics Evaluation and Research … new dosage formulations and improved safety). 2024 Biological License Application Approvals 2024 Biological …
2023 Biological Approvals
… ines-blood-biologics/development-approval-process-cber/2023-biological-approvals … The Center for Biologics Evaluation and Research … new dosage formulations and improved safety). 2023 Biological License Application Approvals 2023 Biological …
2020 Biological Approvals
… ines-blood-biologics/development-approval-process-cber/2020-biological-approvals … The Center for Biologics Evaluation and Research … new dosage formulations and improved safety). 2020 Biological License Application Approvals 2020 Biological …
2021 Biological Approvals
… ines-blood-biologics/development-approval-process-cber/2021-biological-approvals … The Center for Biologics Evaluation and Research … new dosage formulations and improved safety). 2021 Biological License Application Approvals 2021 Biological …
2024 Biological Device Application Approvals
… ines-blood-biologics/development-approval-process-cber/2024-biological-device-application-approvals … This list reflects information regarding the … are listed in order by date of approval / clearance. 2024 Biological Device Application Approvals Tradename/Common Name …
2022 Biological License Application Approvals
… ines-blood-biologics/development-approval-process-cber/2022-biological-license-application-approvals … This list reflects information regarding the … by date of approval in reverse chronological order. 2022 Biological License Application Approvals Tradename/ Proper …
2020 Biological License Application Approvals
… ines-blood-biologics/development-approval-process-cber/2020-biological-license-application-approvals … This list reflects information regarding the … by date of approval in reverse chronological order. 2020 Biological License Application Approvals Tradename/ Proper …
2023 Biological License Application Approvals
… ines-blood-biologics/development-approval-process-cber/2023-biological-license-application-approvals … This list reflects information regarding the … The applications are listed by date of approval. 2023 Biological License Application Approvals Tradename/ Proper …
2021 Biological License Application Approvals
… ines-blood-biologics/development-approval-process-cber/2021-biological-license-application-approvals … This list reflects information regarding the … by date of approval in reverse chronological order. 2021 Biological License Application Approvals Tradename/ Proper …
2024 Biological License Application Approvals
… ines-blood-biologics/development-approval-process-cber/2024-biological-license-application-approvals … This list reflects information regarding the … The applications are listed by date of approval. 2024 Biological License Application Approvals Tradename/ Proper …
2021 Biological Device Application Approvals
… ines-blood-biologics/development-approval-process-cber/2021-biological-device-application-approvals … This list reflects information regarding the … approval / clearance in reverse chronological order. 2021 Biological Device Application Approvals Tradename/Common Name …
2022 Biological License Application Supplement Noteworthy Approvals
… r/2022-biological-license-application-supplement-noteworthy-approvals … This list reflects information regarding the … of approval, with the most recent action at the top. 2022 Biological License Application Supplement Noteworthy Approvals Tradename /Proper Name Indication for Use STN …
2020 Biological License Application Supplement Noteworthy Approvals
… r/2020-biological-license-application-supplement-noteworthy-approvals … This list reflects information regarding the … of approval, with the most recent action at the top. 2020 Biological License Application Supplement Noteworthy Approvals Tradename /Proper Name Indication for Use STN …
2021 Biological License Application Supplement Noteworthy Approvals
… r/2021-biological-license-application-supplement-noteworthy-approvals … This list reflects information regarding the … of approval, with the most recent action at the top. 2021 Biological License Application Supplement Noteworthy Approvals Tradename /Proper Name Indication for Use STN …
2023 Biological License Application Supplement Noteworthy Approvals
… r/2023-biological-license-application-supplement-noteworthy-approvals … This list reflects information regarding the … of approval, with the most recent action at the top. 2023 Biological License Application Supplement Noteworthy Approvals Tradename /Proper Name Indication for Use STN …
2024 Biological License Application Supplement Noteworthy Approvals
… r/2024-biological-license-application-supplement-noteworthy-approvals … This list reflects information regarding the … of approval, with the most recent action at the top. 2024 Biological License Application Supplement Noteworthy Approvals Tradename /Proper Name Indication for Use STN …
2022 Biological Device Application Approvals
… ines-blood-biologics/development-approval-process-cber/2022-biological-device-application-approvals … This list reflects information regarding the … approval / clearance in reverse chronological order. 2022 Biological Device Application Approvals Tradename/Common Name …
2023 Biological Device Application Approvals
… ines-blood-biologics/development-approval-process-cber/2023-biological-device-application-approvals … This list reflects information regarding the … are listed in order by date of approval / clearance. 2023 Biological Device Application Approvals Tradename/Common Name …
2020 Biological Device Application Approvals
… ines-blood-biologics/development-approval-process-cber/2020-biological-device-application-approvals … This list reflects information regarding the … approval / clearance in reverse chronological order. 2020 Biological Device Application Approvals Tradename/Common Name …
2022 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
… g-application-nda-and-abbreviated-new-drug-application-anda-approvals … This list reflects information regarding the … regard to applicant or application status changes. 2022 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals Tradename Indication for Use NDA Number Applicant …
Biological Approvals by Year
… /vaccines-blood-biologics/development-approval-process-cber/biological-approvals-year … The Center for Biologics Evaluation and … under a variety of regulatory authorities. The annual biological approvals are broken into lists based on these …
Therapeutic Biological Products Approvals
… /drugs/therapeutic-biologics-applications-bla/therapeutic-biological-products-approvals … This page was last updated in 2003 To view … . For the latest approval information on therapeutic biological products regulated by CDER, please see Drugs@FDA . …
Licensed Biological Products with Supporting Documents
… /vaccines-blood-biologics/licensed-biological-products-supporting-documents … | A | B | C | D | … product(s). Information is provided for original product approvals, new indications, and the current package insert. Licensed Biological Products with Supporting Documents Product Trade …
Biologics Products & Establishments
… … This page contains a listing of biological product approvals and clearances with supporting documents; … 510(k) Submissions with Supporting Documents Licensed Biological Products with Supporting Documents New Drug …