Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019546
Company: SMITHKLINE BEECHAM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DYNACIRC ISRADIPINE 2.5MG CAPSULE;ORAL Discontinued None Yes No
DYNACIRC ISRADIPINE 5MG CAPSULE;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
12/20/1990 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-546_Isradipine.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/18/2005 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019546s031,020336s013ltr.pdf
06/14/2002 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/29/2002 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/30/2001 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1999 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/28/1999 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/14/1997 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/27/1995 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/04/1995 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1995 SUPPL-13 Labeling

Label is not available on this site.

11/03/1993 SUPPL-12 Labeling

Label is not available on this site.

03/23/1993 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/08/1993 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1992 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/06/1991 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1991 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/1991 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/13/1991 SUPPL-5 Labeling

Label is not available on this site.

06/12/1991 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/13/1991 SUPPL-2 Labeling

Label is not available on this site.

04/30/1991 SUPPL-1 Manufacturing (CMC)-Packaging

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