Details for New Drug Application (NDA): 215456
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NDA 215456 describes THIOTHIXENE, which is a drug marketed by Am Therap, Amneal, Chartwell Rx, Epic Pharma Llc, Novitium Pharma, Rising, Watson Labs, Alpharma Us Pharms, Paco, Teva, Teva Pharms, and Hikma, and is included in twenty-two NDAs. It is available from three suppliers. Additional details are available on the THIOTHIXENE profile page.
The generic ingredient in THIOTHIXENE is thiothixene hydrochloride. There are six drug master file entries for this compound. Additional details are available on the thiothixene hydrochloride profile page.
The generic ingredient in THIOTHIXENE is thiothixene hydrochloride. There are six drug master file entries for this compound. Additional details are available on the thiothixene hydrochloride profile page.
Summary for 215456
| Tradename: | THIOTHIXENE |
| Applicant: | Amneal |
| Ingredient: | thiothixene |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215456
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THIOTHIXENE | thiothixene | CAPSULE;ORAL | 215456 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1673 | 60219-1673-1 | 100 CAPSULE in 1 BOTTLE, PLASTIC (60219-1673-1) |
| THIOTHIXENE | thiothixene | CAPSULE;ORAL | 215456 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1673 | 60219-1673-7 | 1000 CAPSULE in 1 BOTTLE, PLASTIC (60219-1673-7) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1MG | ||||
| Approval Date: | Feb 28, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2MG | ||||
| Approval Date: | Feb 28, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | Feb 28, 2022 | TE: | AB | RLD: | No | ||||
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