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

Medical Subject Heading (MeSH) Categories for 015539

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 006

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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

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