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
CYTOXAN از شرکت BAXTER HLTHCARE
New Drug Application (NDA): 012142
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYTOXAN | CYCLOPHOSPHAMIDE | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| CYTOXAN | CYCLOPHOSPHAMIDE | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| LYOPHILIZED CYTOXAN | CYCLOPHOSPHAMIDE | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| LYOPHILIZED CYTOXAN | CYCLOPHOSPHAMIDE | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 11/16/1959 | ORIG-1 | Approval |
Type 2 – New Active Ingredient |
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 |
|---|---|---|---|---|---|
| 10/31/2016 | SUPPL-115 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/2014 | SUPPL-114 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/2013 | SUPPL-112 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012141s090,012142s112lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012141Orig1s090,012142Orig1s112ltr.pdf |
||
| 03/31/2012 | SUPPL-109 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012142s109lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/012142s109ltr.pdf |
||
| 11/07/2003 | SUPPL-107 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12142scf107ltr.pdf |
|
| 11/02/2000 | SUPPL-104 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/2001 | SUPPL-103 | Labeling |
Label is not available on this site. |
||
| 05/28/1999 | SUPPL-102 | Labeling |
Label is not available on this site. |
||
| 06/15/2000 | SUPPL-101 | Labeling |
Label is not available on this site. |
||
| 12/20/1995 | SUPPL-98 | Labeling |
Label is not available on this site. |
||
| 10/22/1990 | SUPPL-93 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1989 | SUPPL-92 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/12/1988 | SUPPL-91 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/1988 | SUPPL-90 | Labeling |
Label is not available on this site. |
||
| 11/20/1987 | SUPPL-89 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1987 | SUPPL-88 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1986 | SUPPL-87 | Labeling |
Label is not available on this site. |
||
| 12/08/1986 | SUPPL-86 | Labeling |
Label is not available on this site. |
||
| 05/30/1986 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 05/30/1986 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 07/11/1986 | SUPPL-83 | Labeling |
Label is not available on this site. |
||
| 07/11/1986 | SUPPL-82 | Labeling |
Label is not available on this site. |
||
| 07/11/1986 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 05/30/1986 | SUPPL-80 | Labeling |
Label is not available on this site. |
||
| 04/28/1988 | SUPPL-79 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/14/1986 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 08/30/1985 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
| 08/30/1985 | SUPPL-75 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/02/1985 | SUPPL-74 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/18/1985 | SUPPL-73 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/06/1985 | SUPPL-72 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/10/1984 | SUPPL-71 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/10/1985 | SUPPL-70 | Labeling |
Label is not available on this site. |
||
| 09/24/1985 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
| 12/05/1985 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 07/18/1984 | SUPPL-67 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/15/1984 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/20/1984 | SUPPL-65 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/24/1984 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/1984 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 10/17/1984 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 04/05/1984 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 01/04/1984 | SUPPL-58 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/06/1985 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/15/1983 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 06/14/1984 | SUPPL-55 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/30/1982 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/29/1987 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 07/28/1982 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/13/1981 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/16/1981 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/11/1981 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/21/1981 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/27/1980 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 08/03/1979 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/19/1979 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1979 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/13/1978 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/03/1979 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1978 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/20/1977 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/26/1977 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/26/1977 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/1976 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 06/10/1976 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1987 | SUPPL-28 | Efficacy-New Indication |
Label is not available on this site. |
||
| 01/13/1976 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/07/2013 | SUPPL-112 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012141s090,012142s112lbl.pdf | |
| 03/31/2012 | SUPPL-109 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012142s109lbl.pdf |
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