Bendectin
Doxylamine Succinate; Pyridoxine Hydrochloride
Sourced from the FDA Orange Book
Key dates
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Pharmaceutical detail
Active ingredient
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Strength
10MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 010598
Product number
002
Marketing status
Discontinued
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
This is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2016BonjestaBrand (NDA)
NDA 209661 · Duchesnay
- 2013DiclegisBrand (NDA)
NDA 021876 · Duchesnay
- 2023Doxylamine Succinate And Pyridoxine HydrochlorideGeneric (ANDA)
ANDA 217000 · Bionpharma
- 2022Doxylamine Succinate And Pyridoxine HydrochlorideGeneric (ANDA)
ANDA 212472 · Actavis Labs Fl Inc
- 2020Doxylamine Succinate And Pyridoxine HydrochlorideGeneric (ANDA)
ANDA 207825 · Pharmobedient
- 2017Doxylamine Succinate And Pyridoxine HydrochlorideGeneric (ANDA)
ANDA 208518 · Ph Health
- 2016Doxylamine Succinate And Pyridoxine HydrochlorideGeneric (ANDA)
ANDA 205811 · Actavis Labs Fl Inc
Listed patents
Listed patents
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.
Bendectin — frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.
Built directly from the FDA Orange Book data file. This product page links back to the Doxylamine Succinate; Pyridoxine Hydrochloride active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
