Drugs@FDA: FDA-Approved Drugs
Company: SMITHKLINE BEECHAM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DYNACIRC | ISRADIPINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| DYNACIRC | ISRADIPINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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. |
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| 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. |
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| 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. |
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| 06/13/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 04/30/1991 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |