FDA Orange Book · active-ingredient family
Doxylamine succinate
Doxylamine succinate: 3 brands, 5 generics; first approved Aug 07, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
5
Listed patents
0
Presentations
9
Brand (NDA) products
Originator applications
- CHATTEMNDA 018066—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL OTC — - PFIZERNDA 0194401986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - SANOFI AVENTIS USNDA 006412—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 12.5MG TABLET ORAL Discontinued —
Generic (ANDA) products (5)
Abbreviated applications
- DOXYLAMINE SUCCINATELNKANDA 0405642004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL OTC — - DOXYLAMINE SUCCINATEPERRIGOANDA 0401671996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL OTC — - DOXYLAMINE SUCCINATECOPLEY PHARMANDA 0889001988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - PAR PHARMANDA 0701561987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - DOXYLAMINE SUCCINATEQUANTUM PHARMICSANDA 0886031984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET 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
42 yr 8 mo ago
Most recent approval
22 yr 4 mo ago
Approvals span 1984–2004 across 8 FDA applications.
Brand (NDA) 338%
Generic (ANDA) 563%
Doxylamine succinate: 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.
