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
AKINETON از شرکت ABBVIE
New Drug Application (NDA): 012003
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AKINETON | BIPERIDEN HYDROCHLORIDE | 2MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 09/08/1959 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/09/2002 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/2002 | SUPPL-24 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12003s24ltr.pdf |
|
| 10/25/2000 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/17/1987 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/2001 | SUPPL-21 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf |
|
| 07/23/2001 | SUPPL-20 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf |
|
| 07/23/2001 | SUPPL-19 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf |
|
| 07/23/2001 | SUPPL-18 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf |
|
| 01/30/1980 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/29/1976 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/14/1976 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/24/1975 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/12/1975 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/02/1975 | SUPPL-10 | Labeling |
Label is not available on this site. |
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