Nitisinone is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Analog Pharma. The primary component is Nitisinone.
Product ID | 70505-205_6f0fe86a-1c6f-4d95-9355-6bf558cbcaa8 |
NDC | 70505-205 |
Product Type | Human Prescription Drug |
Proprietary Name | Nitisinone |
Generic Name | Nitisinone |
Dosage Form | Capsule |
Route of Administration | ORAL |
Marketing Start Date | 2022-06-15 |
Marketing Category | ANDA / |
Application Number | ANDA212390 |
Labeler Name | Analog Pharma |
Substance Name | NITISINONE |
Active Ingredient Strength | 5 mg/1 |
Pharm Classes | 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2E1 Inducers [MoA], Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2022-06-15 |
NDC Exclude Flag | N |
Sample Package? | N |
NDC | Brand Name | Generic Name |
---|---|---|
0254-3020 | Nitisinone | Nitisinone |
0254-3021 | Nitisinone | Nitisinone |
0254-3022 | Nitisinone | Nitisinone |
63629-2233 | Nitisinone | Nitisinone |
63629-2234 | Nitisinone | Nitisinone |
63629-2235 | Nitisinone | Nitisinone |
70505-202 | Nitisinone | Nitisinone |
70505-205 | Nitisinone | Nitisinone |
70505-210 | Nitisinone | Nitisinone |
70954-010 | Nitisinone | Nitisinone |
70954-008 | Nitisinone | Nitisinone |
70954-009 | Nitisinone | Nitisinone |
70709-000 | NITYR | Nitisinone |
70709-002 | NITYR | Nitisinone |
70709-005 | NITYR | Nitisinone |
66658-102 | Orfadin | Nitisinone |
66658-105 | Orfadin | Nitisinone |
66658-110 | Orfadin | Nitisinone |
66658-120 | Orfadin | Nitisinone |
66658-204 | ORFADIN | nitisinone |