Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207798
Company: UMEDICA LABS PVT LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET;ORAL Prescription AB No No
CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET;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
04/15/2020 ORIG-1 Approval STANDARD

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CARBAMAZEPINE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET;ORAL Prescription No AB 077272 TORRENT PHARMS
CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET;ORAL Prescription No AB 207798 UMEDICA LABS PVT LTD

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET;ORAL Prescription No AB 075948 APOTEX INC
CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET;ORAL Prescription No AB 074649 TARO
CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET;ORAL Prescription No AB 077272 TORRENT PHARMS
CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET;ORAL Prescription No AB 207798 UMEDICA LABS PVT LTD
EPITOL CARBAMAZEPINE 200MG TABLET;ORAL Prescription No AB 070541 TEVA
TEGRETOL CARBAMAZEPINE 200MG TABLET;ORAL Prescription Yes AB 016608 NOVARTIS

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