Details for New Drug Application (NDA): 211041
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NDA 211041 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 is one drug master file entry 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 is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
Summary for 211041
| Tradename: | NITISINONE |
| Applicant: | Novitium Pharma |
| Ingredient: | nitisinone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211041
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITISINONE | nitisinone | CAPSULE;ORAL | 211041 | ANDA | Par Health USA, LLC | 0254-3020 | 0254-3020-02 | 1 BOTTLE in 1 CARTON (0254-3020-02) / 60 CAPSULE in 1 BOTTLE |
| NITISINONE | nitisinone | CAPSULE;ORAL | 211041 | ANDA | Par Health USA, LLC | 0254-3021 | 0254-3021-02 | 1 BOTTLE in 1 CARTON (0254-3021-02) / 60 CAPSULE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2MG | ||||
| Approval Date: | Aug 26, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | Aug 26, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 26, 2019 | TE: | AB | RLD: | No | ||||
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