Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020070
Company: SHIONOGI INC
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 |
Letter (PDF)
|
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) |
Letter (PDF)
|
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 |
Review (PDF)
|
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 |
Review (PDF)
|
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. |