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): 014691

Company: APOTEX

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
ALKERANMELPHALAN2MGTABLET;ORALDiscontinued

None

YesNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
01/17/1964ORIG-1 Approval

Type 1 – New Molecular Entity

PRIORITY

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
05/02/2011SUPPL-30 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s030lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014691s030ltr.pdf

06/09/2011SUPPL-29 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s029lbl.pdf

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

06/09/2005SUPPL-28 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/014691s028ltr.pdf

05/14/2003SUPPL-24 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/14691slr024_alkeran_lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/14691slr024ltr.pdf

01/07/2002SUPPL-23 Labeling

Letter (PDF)

Label is not available on this site.

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

10/09/2001SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/2001SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/24/2001SUPPL-20 Manufacturing (CMC)-Control

Letter (PDF)

Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/14691s20ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/NDA/2001/14-691S20_Alkeran.cfm

07/14/1999SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1998SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1994SUPPL-16 Labeling

Label is not available on this site.

09/26/1989SUPPL-15 Labeling

Label is not available on this site.

03/26/1990SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1987SUPPL-13 Labeling

Label is not available on this site.

09/22/1986SUPPL-12 Labeling

Label is not available on this site.

09/19/1984SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1984SUPPL-10 Labeling

Label is not available on this site.

03/24/1982SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/16/1980SUPPL-7 Labeling

Label is not available on this site.

06/16/1980SUPPL-6 Labeling

Label is not available on this site.

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
06/09/2011SUPPL-29

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s029lbl.pdf
05/02/2011SUPPL-30

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s030lbl.pdf
05/14/2003SUPPL-24

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/14691slr024_alkeran_lbl.pdf
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