Dicloxacillin sodium
Dicloxacillin sodium: 3 brands, 6 generics; first approved Jun 03, 1982; generic available.
Generic available: 6 ANDA applications approved.
Brand (NDA) products
- PATHOCILRLDWYETH AYERSTNDA 050011—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — EQ 500MG BASE CAPSULE ORAL Discontinued — - APOTHECONNDA 050337—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 62.5MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - WYETH AYERSTNDA 050092—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 62.5MG BASE/5ML FOR SUSPENSION ORAL Discontinued —
Generic (ANDA) products (6)
- DICLOXACILLIN SODIUMAUROBINDO PHARMAANDA 21684520222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Rx AB EQ 500MG BASE CAPSULE ORAL Rx AB - DICLOXACILLIN SODIUMCHARTWELL RXANDA 06228619822 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Rx AB EQ 500MG BASE CAPSULE ORAL Rx AB - DICLOXACILLIN SODIUMCHARTWELL RXANDA 061454—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — EQ 125MG BASE CAPSULE ORAL Discontinued — EQ 500MG BASE CAPSULE ORAL Discontinued — - GLAXOSMITHKLINEANDA 060254—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — EQ 500MG BASE CAPSULE ORAL Discontinued — - GLAXOSMITHKLINEANDA 062238—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — EQ 500MG BASE CAPSULE ORAL Discontinued — - DICLOXACILLIN SODIUMAPOTHECONANDA 061455—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 62.5MG BASE/5ML FOR SUSPENSION ORAL Discontinued —
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.
Approval history
Approvals span 1982–2022 across 9 FDA applications.
Dicloxacillin sodium: 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.
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