Drugs@FDA: FDA-Approved Drugs
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| PARAFON FORTE DSC | CHLORZOXAZONE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/15/1958 | 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. |
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| 07/27/2000 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/13/2000 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/04/1996 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/19/1994 | SUPPL-49 | Labeling |
Label is not available on this site. |
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| 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. |
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| 12/16/1991 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/28/1992 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/18/1989 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/10/1992 | SUPPL-41 | Labeling |
Label is not available on this site. |
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| 06/15/1987 | SUPPL-36 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 08/25/1986 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/15/1985 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/20/1986 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/29/1984 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/27/1983 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/16/1983 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/29/1983 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/29/1983 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/29/1983 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/27/1981 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 04/29/1977 | SUPPL-12 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 08/23/1976 | SUPPL-11 | Labeling |
Label is not available on this site. |