Drugs@FDA: FDA Approved Drug Products

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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 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.

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