Nitisinone
- Product NDC
- 70954-009
- 11-digit product format
- 709540009
- Labeler code
- 70954
- Product ID
- 70954-009_cf72aab3-f579-4537-9ca1-a02adbd86037
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitisinone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Novitium Pharma LLC
- Application
- ANDA211041
- Marketing category
- ANDA
- Marketing start
- 2019-08-26
- Marketing end
- 0000-00-00
- Substance
- NITISINONE
- Active strength
- 5 mg/1
- Pharmacologic classes
- 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record