FDA Orange Book · active-ingredient family
Fosfomycin tromethamine
Fosfomycin tromethamine: 1 brand, 8 generics; first approved Dec 19, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 8 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
8
Listed patents
0
Presentations
9
Brand (NDA) products
Originator applications
- MONUROLRLDZAMBON SPANDA 0507171996
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3GM BASE/PACKET FOR SOLUTION ORAL Discontinued —
Generic (ANDA) products (8)
Abbreviated applications
- FOSFOMYCIN TROMETHAMINENOVITIUM PHARMAANDA 2104262026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3GM BASE/PACKET FOR SOLUTION ORAL Rx AA - FOSFOMYCIN TROMETHAMINEAUCTAANDA 2177722026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3GM BASE/PACKET FOR SOLUTION ORAL Rx AA - FOSFOMYCIN TROMETHAMINEAUROBINDO PHARMA LTDANDA 2176082025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3GM BASE/PACKET FOR SOLUTION ORAL Rx AA - FOSFOMYCIN TROMETHAMINEPRECISION DOSE INCANDA 2171872025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3GM BASE/PACKET FOR SOLUTION ORAL Rx AA - FOSFOMYCIN TROMETHAMINEAMNEALANDA 2166002024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3GM BASE/PACKET FOR SOLUTION ORAL Rx AA - FOSFOMYCIN TROMETHAMINECIPLAANDA 2118812022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3GM BASE/PACKET FOR SOLUTION ORAL Rx AA - FOSFOMYCIN TROMETHAMINEALKEM LABS LTDANDA 2145542021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3GM BASE/PACKET FOR SOLUTION ORAL Rx AA - FOSFOMYCIN TROMETHAMINERSXIROMEDANDA 2125482020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3GM BASE/PACKET FOR SOLUTION ORAL Rx AA
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
30 yr 2 mo ago
Most recent approval
1 mo ago
Approvals span 1996–2026 across 9 FDA applications.
Brand (NDA) 111%
Generic (ANDA) 889%
Fosfomycin tromethamine: 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.
