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 Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALKERAN | MELPHALAN | 2MG | TABLET;ORAL | Discontinued |
None |
Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/17/1964 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/02/2011 | SUPPL-30 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014691s030ltr.pdf |
||
| 06/09/2011 | SUPPL-29 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014691s029,020207s016ltr.pdf |
||
| 06/09/2005 | SUPPL-28 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/014691s028ltr.pdf |
|
| 05/14/2003 | SUPPL-24 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/14691slr024_alkeran_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/14691slr024ltr.pdf |
||
| 01/07/2002 | SUPPL-23 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14691s23ltr.pdf |
|
| 10/09/2001 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/09/2001 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
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 |
|
| 07/14/1999 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/22/1998 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/25/1994 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 09/26/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/26/1990 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/09/1987 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/22/1986 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/19/1984 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/1984 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/24/1982 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/16/1980 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/16/1980 | SUPPL-6 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/09/2011 | SUPPL-29 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s029lbl.pdf | |
| 05/02/2011 | SUPPL-30 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s030lbl.pdf | |
| 05/14/2003 | SUPPL-24 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/14691slr024_alkeran_lbl.pdf |
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