Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020398
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPULSID | CISAPRIDE MONOHYDRATE | EQ 1MG BASE/ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 09/15/1995 | 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 |
|---|---|---|---|---|---|
| 03/06/2000 | SUPPL-22 | 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-20 | 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-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1999 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/12/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/31/1998 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 09/22/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/28/1997 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/31/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |