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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 015539
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SERAX OXAZEPAM 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No
SERAX OXAZEPAM 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No
SERAX OXAZEPAM 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No
SERAX OXAZEPAM 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None No No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.
04/05/2000 SUPPL-53 Labeling

Label is not available on this site.
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.
11/17/1989 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.
07/21/1988 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.
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.
07/16/1986 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.
02/02/1984 SUPPL-27 Labeling

Label is not available on this site.
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.
12/03/1979 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/24/1978 SUPPL-13 Labeling

Label is not available on this site.
05/07/1975 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
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
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