FDA Orange Book · active-ingredient family
Cloxacillin sodium
Cloxacillin sodium: 1 brand, 7 generics; first approved Apr 06, 1989; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 7 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
7
Listed patents
0
Presentations
12
Brand (NDA) products
Originator applications
- APOTHECONNDA 050192—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML FOR SOLUTION ORAL Discontinued —
Generic (ANDA) products (7)
Abbreviated applications
- CLOXACILLIN SODIUMTEVAANDA 0629781989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML FOR SOLUTION ORAL Discontinued — - CLOXACILLIN SODIUMAPOTHECONANDA 061452—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 — - CLOXACILLIN SODIUMTEVAANDA 062240—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 061806—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 062233—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 — - CLOXACILLIN SODIUMTEVAANDA 062268—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML FOR SOLUTION ORAL Discontinued — - APOTHECONANDA 061453—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML FOR SOLUTION ORAL 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
37 yr 11 mo ago
Most recent approval
37 yr 11 mo ago
All 8 applications were approved in 1989.
Brand (NDA) 113%
Generic (ANDA) 788%
Cloxacillin 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.
