Details for New Drug Application (NDA): 212390
✉ Email this page to a colleague
NDA 212390 describes NITISINONE, which is a drug marketed by Eton, Medunik, Novitium Pharma, and Torrent, and is included in four NDAs. It is available from four suppliers. Additional details are available on the NITISINONE profile page.
The generic ingredient in NITISINONE is nitisinone. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
The generic ingredient in NITISINONE is nitisinone. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
Summary for 212390
| Tradename: | NITISINONE |
| Applicant: | Medunik |
| Ingredient: | nitisinone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212390
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITISINONE | nitisinone | CAPSULE;ORAL | 212390 | ANDA | Analog Pharma | 70505-202 | 70505-202-60 | 1 BOTTLE, PLASTIC in 1 CARTON (70505-202-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC |
| NITISINONE | nitisinone | CAPSULE;ORAL | 212390 | ANDA | Analog Pharma | 70505-205 | 70505-205-60 | 1 BOTTLE, PLASTIC in 1 CARTON (70505-205-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2MG | ||||
| Approval Date: | May 26, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | May 26, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | May 26, 2022 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
