Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213729
Company: NOVITIUM PHARMA
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 |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/22/2022 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
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 | 213395 | NAVINTA LLC |
CARGLUMIC ACID | CARGLUMIC ACID | 200MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 213729 | NOVITIUM PHARMA |