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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. Eight suppliers are listed for this compound. Additional details are available on the oxazepam profile page.

Summary for NDA: 015539

Tradename:
SERAX
Applicant:
Alpharma Us Pharms
Ingredient:
oxazepam
Patents:0
Formulation / Manufacturing:see details

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength15MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 006

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength30MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired Orange Book Patents for NDA: 015539

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alpharma Us Pharms
SERAX
oxazepam
CAPSULE;ORAL015539-002Approved Prior to Jan 1, 19824,620,974► subscribe
Alpharma Us Pharms
SERAX
oxazepam
CAPSULE;ORAL015539-006Approved Prior to Jan 1, 19824,620,974► subscribe
Alpharma Us Pharms
SERAX
oxazepam
CAPSULE;ORAL015539-004Approved Prior to Jan 1, 19824,620,974► subscribe
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