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FDA Orange Book · active-ingredient family

Oxazepam

Oxazepam is approved as 1 brand and 22 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SERAX · NDA 015539

1

Brand (NDA)

22

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, tablet

ProductApplicantApplicationTEApproved
SERAXRLD×4ALPHARMA US PHARMSNDA 015539—Approved Prior to Jan 1, 1982

Generic (ANDA) products (22)

ProductApplicantApplicationTEApproved
OXAZEPAM×3LEADINGANDA 218261ABMar 03, 2025
OXAZEPAMWATSON LABSANDA 072953—Sep 28, 1990
OXAZEPAMWATSON LABSANDA 072954—Sep 28, 1990
OXAZEPAMWATSON LABS TEVAANDA 072952—Sep 28, 1990
OXAZEPAM×3EPIC PHARMA LLCANDA 071756ABApr 19, 1988
OXAZEPAM×3ACTAVIS ELIZABETHANDA 072253ABApr 14, 1988
OXAZEPAMAM THERAPANDA 071955—Mar 03, 1988
OXAZEPAMAM THERAPANDA 071956—Mar 03, 1988
OXAZEPAMAM THERAPANDA 071957—Mar 03, 1988
ZAXOPAMQUANTUM PHARMICSANDA 070650—Mar 01, 1988
ZAXOPAMQUANTUM PHARMICSANDA 070640—Mar 01, 1988
ZAXOPAMQUANTUM PHARMICSANDA 070641—Mar 01, 1988
OXAZEPAMMYLANANDA 071713—Oct 20, 1987
OXAZEPAMMYLANANDA 071714—Oct 20, 1987
OXAZEPAMMYLANANDA 071715—Oct 20, 1987
OXAZEPAM×3TP ANDA HOLDINGSANDA 071026ABAug 10, 1987
OXAZEPAMIVAX SUB TEVA PHARMSANDA 070943—Aug 03, 1987
OXAZEPAMIVAX SUB TEVA PHARMSANDA 070944—Aug 03, 1987
OXAZEPAMIVAX SUB TEVA PHARMSANDA 070945—Aug 03, 1987
OXAZEPAMWATSON LABSANDA 071494—Apr 21, 1987
OXAZEPAMPARKE DAVISANDA 071508—Feb 02, 1987
OXAZEPAMSUN PHARM INDUSTRIESANDA 070683—Jan 16, 1987

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.

Oxazepam — frequently asked questions

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

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