Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020398
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.

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