AMIODARONE HYDROCHLORIDE از شرکت WOCKHARDT

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
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

AMIODARONE HYDROCHLORIDE از شرکت WOCKHARDT

Abbreviated New Drug Application (ANDA): 077834

Company: WOCKHARDT

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE50MG/MLINJECTABLE;INJECTIONPrescription

AP

NoNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
10/30/2008ORIG-1 Approval

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
06/22/2020SUPPL-3 Labeling

Label is not available on this site.

08/12/2013SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/21/2012SUPPL-1 Labeling-Package Insert

Label is not available on this site.

AMIODARONE HYDROCHLORIDE

INJECTABLE;INJECTION; 50MG/ML

TE Code = AP

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE50MG/MLINJECTABLE;INJECTIONPrescriptionNoAP204550AUROBINDO PHARMA LTD
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE50MG/MLINJECTABLE;INJECTIONPrescriptionNoAP075761FRESENIUS KABI USA
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE50MG/MLINJECTABLE;INJECTIONPrescriptionNoAP077161GLAND PHARMA LTD
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE50MG/MLINJECTABLE;INJECTIONPrescriptionNoAP077234HIKMA FARMACEUTICA
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE50MG/MLINJECTABLE;INJECTIONPrescriptionNoAP203884HOSPIRA INC
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE50MG/MLINJECTABLE;INJECTIONPrescriptionNoAP203885HOSPIRA INC
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE50MG/MLINJECTABLE;INJECTIONPrescriptionNoAP076217MYLAN INSTITUTIONAL
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE50MG/MLINJECTABLE;INJECTIONPrescriptionNoAP077610WOCKHARDT
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE50MG/MLINJECTABLE;INJECTIONPrescriptionNoAP077834WOCKHARDT
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