FDA Orange Book · active-ingredient family
Dexamethasone acetate
Dexamethasone acetate: 1 brand, 2 generics; first approved May 24, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 2 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
2
Listed patents
0
Presentations
3
Brand (NDA) products
Originator applications
- DECADRON-LARLDMERCKNDA 016675—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 8MG BASE/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (2)
Abbreviated applications
- DEXAMETHASONE ACETATEWATSON LABS TEVAANDA 0877111982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 16MG BASE/ML INJECTABLE INJECTION Discontinued — - DEXAMETHASONE ACETATEWATSON LABSANDA 084315—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 8MG BASE/ML INJECTABLE INJECTION 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 11 mo ago
Most recent approval
44 yr 11 mo ago
All 3 applications were approved in 1982.
Brand (NDA) 133%
Generic (ANDA) 267%
Dexamethasone acetate: 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.
