Drugs@FDA: FDA-Approved Drugs
Company: ALPHARMA US PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SERAX | OXAZEPAM | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
SERAX | OXAZEPAM | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
SERAX | OXAZEPAM | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
SERAX | OXAZEPAM | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
06/04/1965 | 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 |
---|---|---|---|---|---|
11/30/2001 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
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04/05/2000 | SUPPL-53 | Labeling |
Label is not available on this site. |
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08/08/2001 | SUPPL-52 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15539s52lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/15539s52ltr.pdf | |
01/21/1992 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/08/1988 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/01/1989 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/17/1989 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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07/21/1988 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/14/1989 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/07/1987 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/02/1987 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
09/08/1986 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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07/16/1986 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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02/02/1984 | SUPPL-27 | Labeling |
Label is not available on this site. |
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06/11/1986 | SUPPL-21 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
11/22/1985 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
05/29/1980 | SUPPL-17 | Labeling |
Label is not available on this site. |
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12/03/1979 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/24/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
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05/07/1975 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/15/1976 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/08/2001 | SUPPL-52 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15539s52lbl.pdf |