CEFUROXIME SODIUM از شرکت ACS DOBFAR SPA

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

CEFUROXIME SODIUM از شرکت ACS DOBFAR SPA

Abbreviated New Drug Application (ANDA): 064124

Company: ACS DOBFAR SPA

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
CEFUROXIME SODIUMCEFUROXIME SODIUMEQ 7.5GM BASE/VIALINJECTABLE;INJECTIONPrescription

AP

NoNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
05/30/1997ORIG-1 Approval

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
07/31/2008SUPPL-8 Labeling

Label is not available on this site.

11/16/2007SUPPL-7 Labeling

Label is not available on this site.

06/20/2007SUPPL-6 Labeling

Label is not available on this site.

01/31/2007SUPPL-5 Labeling

Label is not available on this site.

09/30/2004SUPPL-3 Labeling

Label is not available on this site.

09/23/1999SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CEFUROXIME SODIUM

INJECTABLE;INJECTION; EQ 7.5GM BASE/VIAL

TE Code = AP

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CEFUROXIME SODIUMCEFUROXIME SODIUMEQ 7.5GM BASE/VIALINJECTABLE;INJECTIONPrescriptionNoAP064124ACS DOBFAR SPA
CEFUROXIME SODIUMCEFUROXIME SODIUMEQ 7.5GM BASE/VIALINJECTABLE;INJECTIONPrescriptionNoAP065046HIKMA FARMACEUTICA
ZINACEFCEFUROXIME SODIUMEQ 7.5GM BASE/VIALINJECTABLE;INJECTIONPrescriptionYesAP050558TELIGENT
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