Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020336
Company: GLAXOSMITHKLINE LLC

Products on NDA 020336

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DYNACIRC CR	ISRADIPINE	5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
DYNACIRC CR	ISRADIPINE	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020336

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.