Orange Book product · Generic (ANDA)
SAPROPTERIN DIHYDROCHLORIDE
SAPROPTERIN DIHYDROCHLORIDE
At a glance
Sep 03, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 03, 2025
10 mo ago
Today
Pharmaceutical detail
Active ingredient
SAPROPTERIN DIHYDROCHLORIDE
Strength
100MG/PACKET
Dosage form
POWDER
Route
ORAL
TE code
AB
Application
ANDA 216432
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
- 2026SAPROPTERIN DIHYDROCHLORIDEGeneric (ANDA)
ANDA 219511 · MICRO LABS
- 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.
