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
CHYMODIACTIN از شرکت DISCURE MEDICAL, LLC
Biologic License Application (BLA): 018663
Company: DISCURE MEDICAL, LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHYMODIACTIN | CHYMOPAPAIN | 10,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| CHYMODIACTIN | CHYMOPAPAIN | 4,000 UNITS/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
No | 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 |
|---|---|---|---|---|---|---|---|
| 11/10/1982 | ORIG-1 | Approval |
N/A |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/24/1994 | SUPPL-29 | Supplement |
Label is not available on this site. |
||
| 06/15/1994 | SUPPL-28 | Supplement |
Label is not available on this site. |
||
| 10/20/1994 | SUPPL-27 | Supplement |
Label is not available on this site. |
||
| 05/19/1993 | SUPPL-25 | Supplement |
Label is not available on this site. |
||
| 10/02/1991 | SUPPL-24 | Supplement |
Label is not available on this site. |
||
| 10/28/1993 | SUPPL-23 | Supplement |
Label is not available on this site. |
||
| 11/28/1989 | SUPPL-22 | Supplement |
Label is not available on this site. |
||
| 07/07/1988 | SUPPL-21 | Supplement |
Label is not available on this site. |
||
| 12/15/1986 | SUPPL-19 | Supplement |
Label is not available on this site. |
||
| 01/15/1987 | SUPPL-18 | Supplement |
Label is not available on this site. |
||
| 07/18/1986 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
| 07/01/1987 | SUPPL-16 | Supplement |
Label is not available on this site. |
||
| 07/18/1985 | SUPPL-15 | Supplement |
Label is not available on this site. |
||
| 08/21/1984 | SUPPL-12 | Supplement |
Label is not available on this site. |
||
| 08/21/1984 | SUPPL-11 | Supplement |
Label is not available on this site. |
||
| 07/18/1984 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
| 07/18/1984 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
| 04/06/1984 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
| 07/09/1984 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
| 04/06/1984 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
| 07/09/1984 | SUPPL-1 | Supplement |
Label is not available on this site. |
نظرات کاربران