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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
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