Orange Book product · Brand (NDA)
WELLBUTRIN SR
BUPROPION HYDROCHLORIDE
At a glance
Oct 04, 1996
Approved
Brand (NDA)
Application
AB1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 04, 1996
30 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
BUPROPION HYDROCHLORIDE
Strength
100MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB1
Application
NDA 020358
Product number
002
Marketing status
RX
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.
