Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016769
Company: ORTHO MCNEIL JANSSEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
URISPAS FLAVOXATE HYDROCHLORIDE 100MG 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
01/15/1970 ORIG-1 Approval Type 1 - New Molecular Entity 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
01/03/2001 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

04/21/2000 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

10/29/1999 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

03/19/1996 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/1994 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/1984 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

10/08/1982 SUPPL-26 Labeling

Label is not available on this site.

09/18/1985 SUPPL-25 Labeling

Label is not available on this site.

05/29/1979 SUPPL-24 Labeling

Label is not available on this site.

01/04/1979 SUPPL-23 Labeling

Label is not available on this site.

05/15/1978 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/15/1978 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/1977 SUPPL-20 Labeling

Label is not available on this site.

07/13/1977 SUPPL-19 Labeling

Label is not available on this site.

04/27/1977 SUPPL-18 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/24/1976 SUPPL-17 Labeling

Label is not available on this site.

09/24/1976 SUPPL-16 Labeling

Label is not available on this site.

08/10/1976 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1976 SUPPL-13 Labeling

Label is not available on this site.

04/19/1976 SUPPL-12 Labeling

Label is not available on this site.

01/09/1976 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1975 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

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