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
COGNEX از شرکت SHIONOGI INC
New Drug Application (NDA): 020070
Company: SHIONOGI INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
COGNEX | TACRINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Discontinued |
None |
No | No |
COGNEX | TACRINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Discontinued |
None |
No | No |
COGNEX | TACRINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE;ORAL | Discontinued |
None |
No | No |
COGNEX | TACRINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;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 |
---|---|---|---|---|---|---|---|
09/09/1993 | 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 |
---|---|---|---|---|---|
06/19/2003 | SUPPL-13 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20070scm012,slr013ltr.pdf |
|
06/19/2003 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20070scm012,slr013ltr.pdf |
|
10/15/1998 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/02/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
07/15/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/10/1997 | SUPPL-6 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020070ap.pdf |
|
02/21/1996 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/10/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020070ap.pdf |
|
06/15/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
06/15/1995 | SUPPL-1 | Labeling |
Label is not available on this site. |
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