Nitisinone
These highlights do not include all the information needed to use NITISINONE CAPSULES safely and effectively. See full prescribing information for NITISINONE CAPSULES. NITISINONE capsules, for oral use Initial U.S. Approval: 2002
Approved
Approval ID
e3e057cc-a2cb-4b8b-8c74-4580543f2a71
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 20, 2023
Manufacturers
FDA
Torrent pharmaceuticals limited
DUNS: 916488547
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nitisinone
PRODUCT DETAILS
NDC Product Code13668-629
Application NumberANDA215908
Marketing CategoryC73584
Route of Administrationoral
Effective DateJanuary 10, 2023
Generic NameNitisinone
INGREDIENTS (6)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
NITISINONEActive
Quantity: 2 mg in 1 1
Code: K5BN214699
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Nitisinone
PRODUCT DETAILS
NDC Product Code13668-631
Application NumberANDA215908
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 10, 2023
Generic NameNitisinone
INGREDIENTS (4)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
NITISINONEActive
Quantity: 10 mg in 1 1
Code: K5BN214699
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
Nitisinone
PRODUCT DETAILS
NDC Product Code13668-632
Application NumberANDA215908
Marketing CategoryC73584
Route of Administrationoral
Effective DateJanuary 10, 2023
Generic NameNitisinone
INGREDIENTS (4)
NITISINONEActive
Quantity: 20 mg in 1 1
Code: K5BN214699
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Nitisinone
PRODUCT DETAILS
NDC Product Code13668-630
Application NumberANDA215908
Marketing CategoryC73584
Route of Administrationoral
Effective DateJanuary 10, 2023
Generic NameNitisinone
INGREDIENTS (4)
NITISINONEActive
Quantity: 5 mg in 1 1
Code: K5BN214699
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT