Drugs@FDA: FDA-Approved Drugs
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| FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |