Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020767
Company: JANSSEN PHARMA
Company: JANSSEN PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROPULSID QUICKSOLV | CISAPRIDE MONOHYDRATE | EQ 20MG BASE | TABLET, ORALLY DISINTEGRATING;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 |
---|---|---|---|---|---|---|---|
11/07/1997 | 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-11 | 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-9 | 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-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/20/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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01/12/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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08/17/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
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07/31/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
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09/22/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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06/26/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |