CEFTRIAXONE از شرکت ACS DOBFAR

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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CEFTRIAXONE از شرکت ACS DOBFAR

Abbreviated New Drug Application (ANDA): 065329

Company: ACS DOBFAR

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
CEFTRIAXONECEFTRIAXONE SODIUMEQ 500MG BASE/VIALINJECTABLE;INJECTIONPrescription

AP

NoNo
CEFTRIAXONECEFTRIAXONE SODIUMEQ 1GM BASE/VIALINJECTABLE;INJECTIONPrescription

AP

NoNo
CEFTRIAXONECEFTRIAXONE SODIUMEQ 2GM BASE/VIALINJECTABLE;INJECTIONPrescription

AP

NoNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
07/24/2008ORIG-1 Approval

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
03/02/2016SUPPL-10 Labeling-Package Insert

Label is not available on this site.

11/07/2014SUPPL-7 Labeling-Package Insert

Label is not available on this site.

05/02/2012SUPPL-6 Labeling-Package Insert

Label is not available on this site.

11/29/2010SUPPL-4 Labeling-Package Insert

Label is not available on this site.

01/24/2010SUPPL-2 Labeling-Package Insert

Label is not available on this site.

10/15/2009SUPPL-1 Labeling

Label is not available on this site.

CEFTRIAXONE

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL

TE Code = AP

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CEFTRIAXONECEFTRIAXONE SODIUMEQ 500MG BASE/VIALINJECTABLE;INJECTIONPrescriptionNoAP065329ACS DOBFAR

INJECTABLE;INJECTION; EQ 1GM BASE/VIAL

TE Code = AP

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CEFTRIAXONECEFTRIAXONE SODIUMEQ 1GM BASE/VIALINJECTABLE;INJECTIONPrescriptionNoAP065329ACS DOBFAR
CEFTRIAXONECEFTRIAXONE SODIUMEQ 1GM BASE/VIALINJECTABLE;INJECTIONPrescriptionNoAP065204SANDOZ INC
CEFTRIAXONECEFTRIAXONE SODIUMEQ 1GM BASE/VIALINJECTABLE;INJECTIONPrescriptionNoAP065180WOCKHARDT
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINERCEFTRIAXONE SODIUMEQ 1GM BASE/VIALINJECTABLE;INJECTIONPrescriptionYesAP050796B BRAUN

INJECTABLE;INJECTION; EQ 2GM BASE/VIAL

TE Code = AP

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CEFTRIAXONECEFTRIAXONE SODIUMEQ 2GM BASE/VIALINJECTABLE;INJECTIONPrescriptionNoAP065329ACS DOBFAR
CEFTRIAXONECEFTRIAXONE SODIUMEQ 2GM BASE/VIALINJECTABLE;INJECTIONPrescriptionNoAP065204SANDOZ INC
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINERCEFTRIAXONE SODIUMEQ 2GM BASE/VIALINJECTABLE;INJECTIONPrescriptionYesAP050796B BRAUN
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