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Last Updated: March 18, 2024

Details for New Drug Application (NDA): 015539


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NDA 015539 describes SERAX, which is a drug marketed by Alpharma Us Pharms and is included in one NDA. Additional details are available on the SERAX profile page.

The generic ingredient in SERAX is oxazepam. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the oxazepam profile page.
Summary for 015539
Tradename:SERAX
Applicant:Alpharma Us Pharms
Ingredient:oxazepam
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 015539

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 006

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 015539

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alpharma Us Pharms SERAX oxazepam CAPSULE;ORAL 015539-002 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Alpharma Us Pharms SERAX oxazepam CAPSULE;ORAL 015539-004 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Alpharma Us Pharms SERAX oxazepam CAPSULE;ORAL 015539-006 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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