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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214998
Company: BRISTOL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAMZYOS MAVACAMTEN 2.5MG CAPSULE;ORAL Prescription None Yes No
CAMZYOS MAVACAMTEN 5MG CAPSULE;ORAL Prescription None Yes No
CAMZYOS MAVACAMTEN 10MG CAPSULE;ORAL Prescription None Yes No
CAMZYOS MAVACAMTEN 15MG CAPSULE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/28/2022 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214998s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214998Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214998Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/22/2022 SUPPL-3 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214998Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/28/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214998s000lbl.pdf
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