Details for New Drug Application (NDA): 216201
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NDA 216201 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 216201
| Tradename: | NITISINONE |
| Applicant: | Eton |
| Ingredient: | nitisinone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216201
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITISINONE | nitisinone | CAPSULE;ORAL | 216201 | ANDA | Eton Pharmaceuticals, Inc. | 71863-119 | 71863-119-60 | 1 BOTTLE in 1 CARTON (71863-119-60) / 60 CAPSULE in 1 BOTTLE |
| NITISINONE | nitisinone | CAPSULE;ORAL | 216201 | ANDA | Eton Pharmaceuticals, Inc. | 71863-120 | 71863-120-60 | 1 BOTTLE in 1 CARTON (71863-120-60) / 60 CAPSULE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2MG | ||||
| Approval Date: | May 25, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | May 25, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | May 25, 2023 | TE: | AB | RLD: | No | ||||
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