Orange Book product · Generic (ANDA)
SAPROPTERIN DIHYDROCHLORIDE
SAPROPTERIN DIHYDROCHLORIDE
At a glance
Jan 08, 2026
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 08, 2026
5 mo ago
Today
Pharmaceutical detail
Active ingredient
SAPROPTERIN DIHYDROCHLORIDE
Strength
100MG/PACKET
Dosage form
POWDER
Route
ORAL
TE code
AB
Application
ANDA 219511
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of SAPROPTERIN DIHYDROCHLORIDE
- 2013KUVANBrand (NDA)
NDA 205065 · BIOMARIN PHARM
- 2007KUVANBrand (NDA)
NDA 022181 · BIOMARIN PHARM
- 2025SAPROPTERIN DIHYDROCHLORIDEGeneric (ANDA)
ANDA 216432 · TP ANDA HOLDINGS
- 2025SAPROPTERIN DIHYDROCHLORIDEGeneric (ANDA)
ANDA 218797 · ZENARA
- 2025SAPROPTERIN DIHYDROCHLORIDEGeneric (ANDA)
ANDA 216797 · AUROBINDO PHARMA
- 2025ZELVYSIAGeneric (ANDA)
ANDA 218645 · AUCTA
- 2022SAPROPTERIN DIHYDROCHLORIDEGeneric (ANDA)
ANDA 215534 · ANNORA PHARMA
- 2022SAPROPTERIN DIHYDROCHLORIDEGeneric (ANDA)
ANDA 215420 · ANNORA PHARMA
- 2022SAPROPTERIN DIHYDROCHLORIDEGeneric (ANDA)
ANDA 215798 · DR REDDYS
- 2021SAPROPTERIN DIHYDROCHLORIDEGeneric (ANDA)
ANDA 207685 · DR REDDYS
- 2021SAPROPTERIN DIHYDROCHLORIDEGeneric (ANDA)
ANDA 209452 · DR REDDYS
- 2019SAPROPTERIN DIHYDROCHLORIDEGeneric (ANDA)
ANDA 207207 · PH HEALTH
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.
