Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017821
Company: JANSSEN RES AND DEV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLEXERIL CYCLOBENZAPRINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
FLEXERIL CYCLOBENZAPRINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
08/26/1977 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/11/2013 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017821s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017821Orig1s051ltr.pdf
11/05/2002 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

10/03/2002 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

02/03/2003 SUPPL-45 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017821s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17821se8-045ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017821_S045_FLEXERIL.pdf
09/15/1998 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1996 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1996 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

08/18/1994 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/1990 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/09/1994 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/08/1988 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/30/1986 SUPPL-29 Labeling

Label is not available on this site.

01/16/1986 SUPPL-26 Labeling

Label is not available on this site.

02/24/1984 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/21/1997 SUPPL-24 Labeling

Label is not available on this site.

01/04/1983 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/13/1982 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1982 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/21/1983 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/26/1981 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/26/1981 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/03/1982 SUPPL-16 Labeling

Label is not available on this site.

12/02/1980 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/10/1980 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/10/1980 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/10/1980 SUPPL-12 Labeling

Label is not available on this site.

08/21/1980 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1979 SUPPL-8 Labeling

Label is not available on this site.

05/03/1979 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/02/1978 SUPPL-4 Labeling

Label is not available on this site.

03/14/1978 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/11/2013 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017821s051lbl.pdf
02/03/2003 SUPPL-45 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017821s045lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English