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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207798
Company: UMEDICA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET;ORAL Prescription BX No No
CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET;ORAL Prescription BX 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
04/15/2020 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
12/22/2023 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

CARBAMAZEPINE

There are no Therapeutic Equivalents.

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