Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011529
Company: JANSSEN R AND D
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PARAFON FORTE DSC CHLORZOXAZONE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
08/15/1958 ORIG-1 Approval Type 4 - New Combination 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
12/01/2000 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

07/27/2000 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

06/13/2000 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

03/04/1996 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

12/19/1994 SUPPL-49 Labeling

Label is not available on this site.

06/28/2002 SUPPL-48 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11529s048ltr.pdf
01/28/1993 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

12/16/1991 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

09/28/1992 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

12/18/1989 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

06/10/1992 SUPPL-41 Labeling

Label is not available on this site.

06/15/1987 SUPPL-36 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/25/1986 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/15/1985 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/20/1986 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/29/1984 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/1983 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1983 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/29/1983 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/29/1983 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/29/1983 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/27/1981 SUPPL-17 Labeling

Label is not available on this site.

04/29/1977 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/23/1976 SUPPL-11 Labeling

Label is not available on this site.

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