Drugs@FDA: FDA-Approved Drugs
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPULSID | CISAPRIDE MONOHYDRATE | EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| PROPULSID | CISAPRIDE MONOHYDRATE | EQ 20MG BASE | TABLET;ORAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 07/29/1993 | 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/pre96/020210_S000_CisaprideTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/06/2000 | SUPPL-32 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20767-S011_Propulsid.pdf |
| 03/06/2000 | SUPPL-30 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20210-S030_Propulsid.pdf |
| 11/10/1999 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/1999 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1999 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1998 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 07/31/1998 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 10/06/1998 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/16/1998 | SUPPL-23 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/22/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1998 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/07/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 01/29/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/15/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1995 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/03/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1995 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/11/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/27/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 12/03/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |