Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020767
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.

01/12/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/17/1998 SUPPL-5 Labeling

Label is not available on this site.

07/31/1998 SUPPL-4 Labeling

Label is not available on this site.

09/22/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/26/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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