CARBAMAZEPINE از شرکت TARO

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
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CARBAMAZEPINE از شرکت TARO

Abbreviated New Drug Application (ANDA): 078115

Company: TARO

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
CARBAMAZEPINECARBAMAZEPINE100MGTABLET, EXTENDED RELEASE;ORALPrescription

AB

NoNo
CARBAMAZEPINECARBAMAZEPINE200MGTABLET, EXTENDED RELEASE;ORALPrescription

AB

NoNo
CARBAMAZEPINECARBAMAZEPINE400MGTABLET, EXTENDED RELEASE;ORALPrescription

AB

NoNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
03/31/2009ORIG-1 Approval

Letter (PDF)

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078115s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/078115Orig1s000BioeqR.pdf

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
02/28/2020SUPPL-19 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/08/2016SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/08/2016SUPPL-12 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/13/2013SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/24/2012SUPPL-5 REMS-Proposal, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

02/23/2010SUPPL-2 Labeling

Label is not available on this site.

CARBAMAZEPINE

TABLET, EXTENDED RELEASE;ORAL; 100MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CARBAMAZEPINECARBAMAZEPINE100MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB212948ANBISON LAB
CARBAMAZEPINECARBAMAZEPINE100MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB213311CSPC OUYI
CARBAMAZEPINECARBAMAZEPINE100MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB078115TARO
CARBAMAZEPINECARBAMAZEPINE100MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB211623UNIQUE PHARM
CARBAMAZEPINECARBAMAZEPINE100MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB205571ZYDUS PHARMS
TEGRETOL-XRCARBAMAZEPINE100MGTABLET, EXTENDED RELEASE;ORALPrescriptionYesAB020234NOVARTIS

TABLET, EXTENDED RELEASE;ORAL; 200MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CARBAMAZEPINECARBAMAZEPINE200MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB212948ANBISON LAB
CARBAMAZEPINECARBAMAZEPINE200MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB213311CSPC OUYI
CARBAMAZEPINECARBAMAZEPINE200MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB078115TARO
CARBAMAZEPINECARBAMAZEPINE200MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB211623UNIQUE PHARM
CARBAMAZEPINECARBAMAZEPINE200MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB205571ZYDUS PHARMS
TEGRETOL-XRCARBAMAZEPINE200MGTABLET, EXTENDED RELEASE;ORALPrescriptionYesAB020234NOVARTIS

TABLET, EXTENDED RELEASE;ORAL; 400MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CARBAMAZEPINECARBAMAZEPINE400MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB212948ANBISON LAB
CARBAMAZEPINECARBAMAZEPINE400MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB213311CSPC OUYI
CARBAMAZEPINECARBAMAZEPINE400MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB078115TARO
CARBAMAZEPINECARBAMAZEPINE400MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB211623UNIQUE PHARM
CARBAMAZEPINECARBAMAZEPINE400MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB205571ZYDUS PHARMS
TEGRETOL-XRCARBAMAZEPINE400MGTABLET, EXTENDED RELEASE;ORALPrescriptionYesAB020234NOVARTIS
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