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FDA Orange Book · active-ingredient family

Dexamethasone sodium phosphate

Dexamethasone sodium phosphate is approved as 7 brand and 46 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DECADRON · NDA 012071

7

Brand (NDA)

46

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · aerosol, aerosol, metered, cream, injectable, ointment, solution/drops

ProductApplicantApplicationTEApproved
DECADRONRLD×2MERCKNDA 012071—Approved Prior to Jan 1, 1982
HEXADROLRLD×3ASPEN GLOBAL INCNDA 014694—Approved Prior to Jan 1, 1982
DECADRONRLDMERCKNDA 011984—Approved Prior to Jan 1, 1982
DEXACORTUCB INCNDA 013413—Approved Prior to Jan 1, 1982
DEXACORTUCB INCNDA 014242—Approved Prior to Jan 1, 1982
DECADRONMERCKNDA 011983—Approved Prior to Jan 1, 1982
DECADRONMERCKNDA 011977—Approved Prior to Jan 1, 1982

Generic (ANDA) products (46)

ProductApplicantApplicationTEApproved
DEXAMETHASONE SODIUM PHOSPHATEMICRO LABSANDA 217797APMar 27, 2024
DEXAMETHASONE SODIUM PHOSPHATEHIKMAANDA 211451—Aug 01, 2023
DEXAMETHASONE SODIUM PHOSPHATE×2GENEYORK PHARMSANDA 214890—Jul 28, 2023
DEXAMETHASONE SODIUM PHOSPHATE×2GLANDANDA 215654APAug 04, 2021
DEXAMETHASONE SODIUM PHOSPHATEEUGIA PHARMAANDA 210966APJun 05, 2020
DEXAMETHASONE SODIUM PHOSPHATEEUGIA PHARMAANDA 210967—Jun 07, 2019
DEXAMETHASONE SODIUM PHOSPHATESOMERSET THERAPS LLCANDA 211036APMay 10, 2019
DEXAMETHASONE SODIUM PHOSPHATEAMNEALANDA 208689APAug 22, 2018
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEAMNEALANDA 208690APAug 22, 2018
DEXAMETHASONE SODIUM PHOSPHATEFRESENIUS KABI USAANDA 209192APJul 06, 2018
DEXAMETHASONE SODIUM PHOSPHATESOMERSETANDA 207521APJun 08, 2018
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREESOMERSET THERAPS LLCANDA 207442APApr 19, 2018
DEXAMETHASONE SODIUM PHOSPHATEEUGIA PHARMAANDA 206781—Dec 01, 2015
DEXAMETHASONE SODIUM PHOSPHATEFRESENIUS KABI USAANDA 203129APSep 30, 2015
DEXAMETHASONE SODIUM PHOSPHATEMYLAN LABS LTDANDA 040803APAug 29, 2008
DEXAMETHASONE SODIUM PHOSPHATEMYLAN LABS LTDANDA 040802APAug 29, 2008
DEXAMETHASONE SODIUM PHOSPHATEFRESENIUS KABI USAANDA 040572APApr 22, 2005
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEFRESENIUS KABI USAANDA 040491APApr 11, 2003
DEXAMETHASONE SODIUM PHOSPHATEBAUSCH AND LOMB INCANDA 040069—Jul 26, 1996
DEXAMETHASONE SODIUM PHOSPHATETEVA PARENTERALANDA 081125—Aug 31, 1990
DEXAMETHASONE SODIUM PHOSPHATETEVA PARENTERALANDA 081126—Aug 31, 1990
DEXAMETHASONE SODIUM PHOSPHATEDR REDDYSANDA 089169—Apr 09, 1986
DEXAMETHASONE SODIUM PHOSPHATECAPLINANDA 088771—Jan 16, 1985
DEXAMETHASONE SODIUM PHOSPHATEINTL MEDICATIONANDA 088522—Feb 17, 1984
DEXAMETHASONEABRAXIS PHARMANDA 088448—Jan 25, 1984
DEXAMETHASONEFRESENIUS KABI USAANDA 088469—Jan 25, 1984
DEXAIRPHARMAFAIRANDA 088433—Dec 15, 1983
DEXAIRPHARMAFAIRANDA 088071—Dec 28, 1982
DEXAMETHASONE SODIUM PHOSPHATEHIKMAANDA 087702APSep 07, 1982
DEXAMETHASONE SODIUM PHOSPHATERLDLUITPOLDANDA 087440—Jul 21, 1982
DEXAMETHASONE SODIUM PHOSPHATEWATSON LABSANDA 087668—Jul 01, 1982
DEXACEN-4CENT PHARMSANDA 084342—Approved Prior to Jan 1, 1982
DEXAMETHASONE SODIUM PHOSPHATEBEL MARANDA 084752—Approved Prior to Jan 1, 1982
DEXAMETHASONE SODIUM PHOSPHATEDELL LABSANDA 083161—Approved Prior to Jan 1, 1982
DEXAMETHASONE SODIUM PHOSPHATEEPIC PHARMA LLCANDA 084493—Approved Prior to Jan 1, 1982
DEXAMETHASONE SODIUM PHOSPHATERLDFRESENIUS KABI USAANDA 084916APApproved Prior to Jan 1, 1982
DEXAMETHASONE SODIUM PHOSPHATEHIKMAANDA 084282APApproved Prior to Jan 1, 1982
DEXAMETHASONE SODIUM PHOSPHATELYPHOMEDANDA 087065—Approved Prior to Jan 1, 1982
DEXAMETHASONE SODIUM PHOSPHATEWATSON LABSANDA 083702—Approved Prior to Jan 1, 1982
DEXAMETHASONE SODIUM PHOSPHATEWATSON LABSANDA 084355—Approved Prior to Jan 1, 1982
DEXAMETHASONE SODIUM PHOSPHATEWATSON LABSANDA 085606—Approved Prior to Jan 1, 1982
DEXAMETHASONE SODIUM PHOSPHATEWYETH AYERSTANDA 085641—Approved Prior to Jan 1, 1982
MAXIDEXALCONANDA 083342—Approved Prior to Jan 1, 1982
DEXAMETHASONE SODIUM PHOSPHATESOLA BARNES HINDANDA 084170—Approved Prior to Jan 1, 1982
DEXAMETHASONE SODIUM PHOSPHATESOLA BARNES HINDANDA 084173—Approved Prior to Jan 1, 1982
DEXAMETHASONE SODIUM PHOSPHATEEPIC PHARMA LLCANDA 084855—Approved Prior to Jan 1, 1982

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.

Dexamethasone sodium phosphate — frequently asked questions

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

Agent CTA Background

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