FDA Orange Book · active-ingredient family
Betaine
Betaine: 1 brand, 2 generics; first approved Oct 25, 1996; generic available.
Generic available
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
- RECORDATI RARENDA 0205761996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/SCOOPFUL FOR SOLUTION ORAL Rx AB
Generic (ANDA) products (2)
Abbreviated applications
- BETAINEETONANDA 2105082022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/SCOOPFUL FOR SOLUTION ORAL Rx AB - BETAINENOVITIUM PHARMAANDA 2148642021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/SCOOPFUL FOR SOLUTION ORAL Rx AB
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 3 mo ago
Most recent approval
4 yr 7 mo ago
Approvals span 1996–2022 across 3 FDA applications.
Brand (NDA) 133%
Generic (ANDA) 267%
Betaine: 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.
