Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213729
Company: NOVITIUM PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARGLUMIC ACID CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/13/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213729Orig1s000ltr.pdf

CARGLUMIC ACID

TABLET, FOR SUSPENSION;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBAGLU CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION;ORAL Prescription Yes AB 022562 RECORDATI RARE
CARGLUMIC ACID CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 213729 NOVITIUM PHARMA

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