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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214277
Company: NOVITIUM PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBAMAZEPINE CARBAMAZEPINE 100MG/5ML 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
10/06/2022 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/09/2024 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

CARBAMAZEPINE

SUSPENSION;ORAL; 100MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBAMAZEPINE CARBAMAZEPINE 100MG/5ML SUSPENSION;ORAL Prescription No AB 075714 CHARTWELL RX
CARBAMAZEPINE CARBAMAZEPINE 100MG/5ML SUSPENSION;ORAL Prescription No AB 214277 NOVITIUM PHARMA
TEGRETOL CARBAMAZEPINE 100MG/5ML SUSPENSION;ORAL Prescription Yes AB 018927 NOVARTIS
TERIL CARBAMAZEPINE 100MG/5ML SUSPENSION;ORAL Prescription No AB 076729 TARO
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