Drugs@FDA: FDA-Approved Drugs
Company: UCB INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LORTAB | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 500MG;5MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/09/1982 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/26/2000 | SUPPL-39 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/29/1999 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/25/1996 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1996 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 09/29/1994 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/21/1994 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/30/1993 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/26/1993 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/26/1993 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1992 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/12/1991 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/1990 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/14/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/14/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/29/1998 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 10/29/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1986 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1985 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/1985 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/1985 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/13/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |