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
CYTARABINE از شرکت TEVA PARENTERAL
New Drug Application (NDA): 016793
Company: TEVA PARENTERAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYTARABINE | CYTARABINE | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| CYTARABINE | CYTARABINE | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| CYTARABINE | CYTARABINE | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| CYTARABINE | CYTARABINE | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 06/17/1969 | 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 |
|---|---|---|---|---|---|
| 04/03/2000 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/15/1998 | SUPPL-59 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/016793s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/016793s059ltr.pdf |
||
| 01/24/1996 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1995 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 09/27/1994 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1990 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 12/21/1987 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 02/24/1987 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/1987 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 12/21/1987 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/28/1986 | SUPPL-46 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/21/1983 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1983 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 12/30/1982 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 03/31/1981 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/23/1979 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 10/29/1979 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 03/10/1976 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/1975 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/24/1974 | SUPPL-25 | Unspecified |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/15/1998 | SUPPL-59 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/016793s059lbl.pdf |
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