Orange Book product · Brand (NDA)
WELLBUTRIN
BUPROPION HYDROCHLORIDE
At a glance
Dec 30, 1985
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 30, 1985
41 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
BUPROPION HYDROCHLORIDE
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 018644
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.
- 2026BUPROPION HYDROCHLORIDEGeneric (ANDA)
ANDA 220529 · YICHANG HUMANWELL
- 2025BUPROPION HYDROCHLORIDEGeneric (ANDA)
ANDA 217898 · ANNORA PHARMA
- 2025BUPROPION HYDROCHLORIDEGeneric (ANDA)
ANDA 207874 · IPCA LABS LTD
- 2024BUPROPION HYDROCHLORIDEGeneric (ANDA)
ANDA 218385 · GRANULES
- 2023BUPROPION HYDROCHLORIDEGeneric (ANDA)
ANDA 216800 · ANNORA PHARMA
- 2023BUPROPION HYDROCHLORIDEGeneric (ANDA)
ANDA 216766 · YICHANG HUMANWELL
- 2022BUPROPION HYDROCHLORIDEGeneric (ANDA)
ANDA 215568 · GRANULES
- 2020BUPROPION HYDROCHLORIDEGeneric (ANDA)
ANDA 203650 · SUN PHARM
- 2020BUPROPION HYDROCHLORIDEGeneric (ANDA)
ANDA 200216 · SUN PHARM
- 2019BUPROPION HYDROCHLORIDEGeneric (ANDA)
ANDA 211020 · GRAVITI PHARMS
- 2018BUPROPION HYDROCHLORIDEGeneric (ANDA)
ANDA 210497 · ACCORD HLTHCARE
- 2018BUPROPION HYDROCHLORIDEGeneric (ANDA)
ANDA 211347 · YICHANG HUMANWELL
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.
