Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020336
Company: GLAXOSMITHKLINE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DYNACIRC CR ISRADIPINE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
DYNACIRC CR ISRADIPINE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No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
06/01/1994 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/18/2005 SUPPL-13 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-7 Manufacturing (CMC)

Label is not available on this site.

04/29/2002 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/14/1999 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/31/1996 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1995 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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