AMBISOME از شرکت ASTELLAS

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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AMBISOME از شرکت ASTELLAS

New Drug Application (NDA): 050740

Company: ASTELLAS

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
AMBISOMEAMPHOTERICIN B50MG/VIALINJECTABLE, LIPOSOMAL;INJECTIONPrescription

None

YesYes
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
08/11/1997ORIG-1 Approval

Type 2 – New Active Ingredient

PRIORITY; Orphan

Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050740_ambisome_toc.cfm

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
02/04/2021SUPPL-33 Labeling-Package Insert, Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050740Orig1s033ltr.pdf

05/12/2020SUPPL-31 Labeling-Package Insert, Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050740Orig1s031ltr.pdf

09/16/2014SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/08/2012SUPPL-21 Labeling-Package Insert

Label (PDF)

Letter (PDF)

Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050740s021lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050740s021ltr.pdf

10/08/2008SUPPL-16 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050740s016lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050740s016ltr.pdf

09/16/2003SUPPL-14 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50740slr014_ambisome_lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50740slr014ltr.pdf

09/06/2002SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/2002SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/27/2002SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/2002SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/04/2001SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/2001SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/2000SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/26/2000SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/29/2000SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/16/2000SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/16/2000SUPPL-2 Efficacy-New Indication

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50740S2LBL.PDF

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50740S2LTR.PDF

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740S2_AmBisome.cfm

01/28/2000SUPPL-1 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740S001_AmBisome_prntlbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740S001_AmBisome_Approv.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/050740s001_ambisome_toc.cfm

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
05/12/2020SUPPL-31

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
05/12/2020SUPPL-31

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
03/08/2012SUPPL-21

Labeling-Package Insert

Label (PDF)

Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050740s021lbl.pdf
10/08/2008SUPPL-16

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050740s016lbl.pdf
09/16/2003SUPPL-14

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50740slr014_ambisome_lbl.pdf
06/16/2000SUPPL-2

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50740S2LBL.PDF
01/28/2000SUPPL-1

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740S001_AmBisome_prntlbl.pdf
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