Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 010251
Company: TARGACEPT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INVERSINE MECAMYLAMINE HYDROCHLORIDE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
03/01/1956 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
10/18/2002 SUPPL-24 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10251scm024ltr.pdf
01/24/2002 SUPPL-23 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/20/2001 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/31/2000 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/31/2000 SUPPL-20 Labeling

Label is not available on this site.

05/31/1996 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/08/1994 SUPPL-18 Labeling

Label is not available on this site.

09/26/1994 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/06/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/22/1988 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1985 SUPPL-14 Labeling

Label is not available on this site.

09/06/1985 SUPPL-13 Labeling

Label is not available on this site.

11/14/1980 SUPPL-12 Labeling

Label is not available on this site.

04/30/1980 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/27/1979 SUPPL-10 Labeling

Label is not available on this site.

09/01/1976 SUPPL-9 Labeling

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English