Is there a generic for Oxazepam?

Yes. The FDA Orange Book lists 22 approved generic (ANDA) applications for Oxazepam, referencing the brand SERAX. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Oxazepam?

SERAX (NDA 015539, ALPHARMA US PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Oxazepam are approved?

Oxazepam is approved in the following dosage forms: capsule, tablet.

FDA Orange Book · active-ingredient family

Oxazepam

Oxazepam: 1 brand, 22 generics; first approved Jan 16, 1987; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 22 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

SERAXRLD

ALPHARMA US PHARMSNDA 015539—4 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE	ORAL	Discontinued	—
15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE	ORAL	Discontinued	—
30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE	ORAL	Discontinued	—
15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (22)

OXAZEPAM

LEADINGANDA 21826120253 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	CAPSULE	ORAL	Rx	AB
15MG	CAPSULE	ORAL	Rx	AB
30MG	CAPSULE	ORAL	Rx	AB

OXAZEPAM

WATSON LABSANDA 0729531990

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Discontinued	—

OXAZEPAM

WATSON LABSANDA 0729541990

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	CAPSULE	ORAL	Discontinued	—

OXAZEPAM

WATSON LABS TEVAANDA 0729521990

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	CAPSULE	ORAL	Discontinued	—

OXAZEPAM

EPIC PHARMA LLCANDA 07175619883 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Rx	AB
10MG	CAPSULE	ORAL	Rx	AB
30MG	CAPSULE	ORAL	Rx	AB

OXAZEPAM

ACTAVIS ELIZABETHANDA 07225319883 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	CAPSULE	ORAL	Rx	AB
10MG	CAPSULE	ORAL	Rx	AB
15MG	CAPSULE	ORAL	Rx	AB

OXAZEPAM

AM THERAPANDA 0719551988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	CAPSULE	ORAL	Discontinued	—

OXAZEPAM

AM THERAPANDA 0719561988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Discontinued	—

OXAZEPAM

AM THERAPANDA 0719571988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	CAPSULE	ORAL	Discontinued	—

ZAXOPAM

QUANTUM PHARMICSANDA 0706501988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	CAPSULE	ORAL	Discontinued	—

ZAXOPAM

QUANTUM PHARMICSANDA 0706401988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Discontinued	—

ZAXOPAM

QUANTUM PHARMICSANDA 0706411988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	CAPSULE	ORAL	Discontinued	—

OXAZEPAM

MYLANANDA 0717131987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	CAPSULE	ORAL	Discontinued	—

OXAZEPAM

MYLANANDA 0717141987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Discontinued	—

OXAZEPAM

MYLANANDA 0717151987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	CAPSULE	ORAL	Discontinued	—

OXAZEPAM

TP ANDA HOLDINGSANDA 07102619873 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	CAPSULE	ORAL	Rx	AB
10MG	CAPSULE	ORAL	Rx	AB
15MG	CAPSULE	ORAL	Rx	AB

OXAZEPAM

IVAX SUB TEVA PHARMSANDA 0709431987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	CAPSULE	ORAL	Discontinued	—

OXAZEPAM

IVAX SUB TEVA PHARMSANDA 0709441987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Discontinued	—

OXAZEPAM

IVAX SUB TEVA PHARMSANDA 0709451987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	CAPSULE	ORAL	Discontinued	—

OXAZEPAM

WATSON LABSANDA 0714941987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	TABLET	ORAL	Discontinued	—

OXAZEPAM

PARKE DAVISANDA 0715081987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	TABLET	ORAL	Discontinued	—

OXAZEPAM

SUN PHARM INDUSTRIESANDA 0706831987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	TABLET	ORAL	Discontinued	—

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Jan 16, 1987

40 yr 1 mo ago

Most recent approval

Mar 03, 2025

1 yr 5 mo ago

Approvals span 1987–2025 across 23 FDA applications.

Brand (NDA) 14%

Generic (ANDA) 2296%

Oxazepam — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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