← FDA DRUG APPROVALS

FDA NDA · NDA020336

DYNACIRC CR

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APPLICATION
NDA020336
TYPE
NDA
ORIGINAL APPROVAL
1994-06-01
LATEST ACTION
2005-05-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

DYNACIRC CR · ReferenceDiscontinued
ISRADIPINE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
DYNACIRC CR · ReferenceDiscontinued
ISRADIPINE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2005-05-18Labeling · Supplement 13 · standard — Letter ↗AP
2002-06-14Manufacturing (CMC) · Supplement 7 · standardAP
2002-04-29Manufacturing (CMC) · Supplement 6 · standardAP
2000-07-18Manufacturing (CMC) · Supplement 4 · standardAP
1999-12-14Manufacturing (CMC) · Supplement 5 · standardAP
1997-04-18Manufacturing (CMC) · Supplement 3 · standardAP
1996-01-31Manufacturing (CMC) · Supplement 2 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 1 · standardAP
1994-06-01Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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