FDA Orange Book · active-ingredient family
Dexamethasone sodium phosphate
Dexamethasone sodium phosphate: 7 brands, 46 generics; first approved Jul 01, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 46 ANDA applications approved.
Brands (NDA)
7
Generics (ANDA)
46
Listed patents
0
Presentations
58
Brand (NDA) products
Originator applications
- DECADRONRLDMERCKNDA 012071—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — EQ 24MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - HEXADROLRLDASPEN GLOBAL INCNDA 014694—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — EQ 20MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DECADRONRLDMERCKNDA 011984—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% PHOSPHATE SOLUTION/DROPS OPHTHALMIC, OTIC Discontinued — - UCB INCNDA 013413—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG PHOSPHATE/INH AEROSOL, METERED INHALATION Discontinued — - UCB INCNDA 014242—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG PHOSPHATE/INH AEROSOL NASAL Discontinued — - MERCKNDA 011983—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% PHOSPHATE CREAM TOPICAL Discontinued — - MERCKNDA 011977—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% PHOSPHATE OINTMENT OPHTHALMIC Discontinued —
Generic (ANDA) products (46)
Abbreviated applications
- DEXAMETHASONE SODIUM PHOSPHATEMICRO LABSANDA 2177972024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - DEXAMETHASONE SODIUM PHOSPHATEHIKMAANDA 2114512023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE SODIUM PHOSPHATEGENEYORK PHARMSANDA 21489020232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE SODIUM PHOSPHATEGLANDANDA 21565420212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - DEXAMETHASONE SODIUM PHOSPHATEEUGIA PHARMAANDA 2109662020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - DEXAMETHASONE SODIUM PHOSPHATEEUGIA PHARMAANDA 2109672019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE SODIUM PHOSPHATESOMERSET THERAPS LLCANDA 2110362019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - DEXAMETHASONE SODIUM PHOSPHATEAMNEALANDA 2086892018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - AMNEALANDA 2086902018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - DEXAMETHASONE SODIUM PHOSPHATEFRESENIUS KABI USAANDA 2091922018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - DEXAMETHASONE SODIUM PHOSPHATESOMERSETANDA 2075212018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - SOMERSET THERAPS LLCANDA 2074422018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - DEXAMETHASONE SODIUM PHOSPHATEEUGIA PHARMAANDA 2067812015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE SODIUM PHOSPHATEFRESENIUS KABI USAANDA 2031292015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - DEXAMETHASONE SODIUM PHOSPHATEMYLAN LABS LTDANDA 0408032008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - DEXAMETHASONE SODIUM PHOSPHATEMYLAN LABS LTDANDA 0408022008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - DEXAMETHASONE SODIUM PHOSPHATERSFRESENIUS KABI USAANDA 0405722005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - FRESENIUS KABI USAANDA 0404912003
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - DEXAMETHASONE SODIUM PHOSPHATERSBAUSCH AND LOMB INCANDA 0400691996
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% PHOSPHATE SOLUTION/DROPS OPHTHALMIC, OTIC Rx — - DEXAMETHASONE SODIUM PHOSPHATETEVA PARENTERALANDA 0811251990
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE SODIUM PHOSPHATETEVA PARENTERALANDA 0811261990
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE SODIUM PHOSPHATEDR REDDYSANDA 0891691986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE SODIUM PHOSPHATECAPLINANDA 0887711985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% PHOSPHATE SOLUTION/DROPS OPHTHALMIC, OTIC Discontinued — - DEXAMETHASONE SODIUM PHOSPHATEINTL MEDICATIONANDA 0885221984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - ABRAXIS PHARMANDA 0884481984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - FRESENIUS KABI USAANDA 0884691984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - PHARMAFAIRANDA 0884331983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% PHOSPHATE SOLUTION/DROPS OPHTHALMIC Discontinued — - PHARMAFAIRANDA 0880711982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% PHOSPHATE OINTMENT OPHTHALMIC Discontinued — - DEXAMETHASONE SODIUM PHOSPHATERSHIKMAANDA 0877021982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - DEXAMETHASONE SODIUM PHOSPHATERLDLUITPOLDANDA 0874401982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE SODIUM PHOSPHATEWATSON LABSANDA 0876681982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - CENT PHARMSANDA 084342—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE SODIUM PHOSPHATEBEL MARANDA 084752—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE SODIUM PHOSPHATEDELL LABSANDA 083161—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE SODIUM PHOSPHATEEPIC PHARMA LLCANDA 084493—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE SODIUM PHOSPHATERLDRSFRESENIUS KABI USAANDA 084916—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - DEXAMETHASONE SODIUM PHOSPHATEHIKMAANDA 084282—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Rx AP - DEXAMETHASONE SODIUM PHOSPHATELYPHOMEDANDA 087065—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE SODIUM PHOSPHATEWATSON LABSANDA 083702—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE SODIUM PHOSPHATEWATSON LABSANDA 084355—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE SODIUM PHOSPHATEWATSON LABSANDA 085606—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 24MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE SODIUM PHOSPHATEWYETH AYERSTANDA 085641—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG PHOSPHATE/ML INJECTABLE INJECTION Discontinued — - ALCONANDA 083342—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% PHOSPHATE OINTMENT OPHTHALMIC Discontinued — - DEXAMETHASONE SODIUM PHOSPHATESOLA BARNES HINDANDA 084170—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% PHOSPHATE SOLUTION/DROPS OPHTHALMIC Discontinued — - DEXAMETHASONE SODIUM PHOSPHATESOLA BARNES HINDANDA 084173—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% PHOSPHATE SOLUTION/DROPS OPHTHALMIC Discontinued — - DEXAMETHASONE SODIUM PHOSPHATEEPIC PHARMA LLCANDA 084855—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% PHOSPHATE SOLUTION/DROPS OTIC Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
44 yr 10 mo ago
Most recent approval
2 yr 5 mo ago
Approvals span 1982–2024 across 53 FDA applications.
Brand (NDA) 713%
Generic (ANDA) 4687%
Dexamethasone sodium phosphate: 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
