Orange Book product · Brand (NDA)
BUSPAR
BUSPIRONE HYDROCHLORIDE
At a glance
Sep 29, 1986
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 29, 1986
40 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
BUSPIRONE HYDROCHLORIDE
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 018731
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2000BUSPARBrand (NDA)
NDA 021190 · BRISTOL MYERS SQUIBB
- 2026BUSPIRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 208972 · EPIC PHARMA LLC
- 2026BUCAPSOLGeneric (ANDA)
ANDA 218628 · EPIC PHARMA LLC
- 2019BUSPIRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 210907 · UNICHEM
- 2018BUSPIRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 209696 · INVENTIA HLTHCARE
- 2017BUSPIRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 208829 · AMNEAL PHARMS CO
- 2015BUSPIRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 202087 · AIPING PHARM INC
- 2015BUSPIRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 204582 · HERITAGE PHARMA
- 2014BUSPIRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 202557 · ACCORD HLTHCARE
- 2014BUSPIRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 202330 · STRIDES PHARMA
- 2014BUSPIRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 078888 · ZYDUS PHARMS
- 2009BUSPIRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 078246 · AUROBINDO PHARMA LTD
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.
