FDA Orange Book · active-ingredient family
Gadoterate meglumine
Gadoterate meglumine: 1 brand, 4 generics; first approved Mar 20, 2013; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
4
Listed patents
0
Presentations
23
Brand (NDA) products
Originator applications
- GUERBETNDA 20478120175 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 37.69GM/100ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP 3.769GM/10ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP 5.6535GM/15ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP 7.538GM/20ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP 1.8845GM/5ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP
Generic (ANDA) products (4)
Abbreviated applications
- GADOTERATE MEGLUMINEVIWIT PHARMANDA 21928620263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.769GM/10ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP 5.6535GM/15ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP 7.538GM/20ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP - GADOTERATE MEGLUMINEHAINAN POLYANDA 21807320245 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.8845GM/5ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP 3.769GM/10ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP 5.6535GM/15ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP 7.538GM/20ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP 37.69GM/100ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP - GADOTERATE MEGLUMINEHENGRUI PHARMAANDA 21530420225 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.8845GM/5ML (376.9MG/ML) SOLUTION INTRAVENOUS Discontinued — 3.769GM/10ML (376.9MG/ML) SOLUTION INTRAVENOUS Discontinued — 5.6535GM/15ML (376.9MG/ML) SOLUTION INTRAVENOUS Discontinued — 7.538GM/20ML (376.9MG/ML) SOLUTION INTRAVENOUS Discontinued — 37.69GM/100ML (376.9MG/ML) SOLUTION INTRAVENOUS Discontinued — - GE HEALTHCAREANDA 21001620205 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.769GM/10ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP 5.6535GM/15ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP 7.538GM/20ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP 37.69GM/100ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP 1.8845GM/5ML (376.9MG/ML) SOLUTION INTRAVENOUS Rx AP
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
13 yr 8 mo ago
Most recent approval
1 mo ago
Approvals span 2013–2026 across 5 FDA applications.
Brand (NDA) 120%
Generic (ANDA) 480%
Gadoterate meglumine: 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.
