Drugs@FDA: FDA-Approved Drugs
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. |
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| 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. |
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| 09/27/1994 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 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. |
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| 09/18/1985 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 05/29/1979 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 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. |
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| 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. |