ALKERAN از شرکت APOTEX

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

ALKERAN از شرکت APOTEX

New Drug Application (NDA): 020207

Company: APOTEX

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
ALKERANMELPHALAN HYDROCHLORIDEEQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE;INJECTIONDiscontinued

None

YesNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
11/18/1992ORIG-1 Approval

Type 3 – New Dosage Form

PRIORITY; Orphan

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
05/02/2011SUPPL-17 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020207s017lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020207s017ltr.pdf

06/09/2011SUPPL-16 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020207s016lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014691s029,020207s016ltr.pdf

06/14/2005SUPPL-12 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020207s012ltr.pdf

04/29/2003SUPPL-7 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20207slr007_alkeran_lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20207slr007ltr.pdf

01/07/2002SUPPL-5 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14691s23ltr.pdf

10/09/2001SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/2001SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/03/2000SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/05/1994SUPPL-1 Labeling

Label is not available on this site.

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
06/09/2011SUPPL-16

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020207s016lbl.pdf
05/02/2011SUPPL-17

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020207s017lbl.pdf
04/29/2003SUPPL-7

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20207slr007_alkeran_lbl.pdf
بخوانید  ABRAXANE از شرکت ABRAXIS BIOSCIENCE
اسکرول به بالا