Details for New Drug Application (NDA): 211251
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NDA 211251 describes TRIENTINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Amneal, Chartwell Rx, Dr Reddys, Eci Pharms Llc, Endo Operations, Hetero Labs Ltd Iii, Lupin Ltd, MSN, Navinta Llc, Rising, Watson Labs Teva, and Zydus Pharms, and is included in thirteen NDAs. It is available from eleven suppliers. Additional details are available on the TRIENTINE HYDROCHLORIDE profile page.
The generic ingredient in TRIENTINE HYDROCHLORIDE is trientine hydrochloride. There are ten drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the trientine hydrochloride profile page.
The generic ingredient in TRIENTINE HYDROCHLORIDE is trientine hydrochloride. There are ten drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the trientine hydrochloride profile page.
Summary for 211251
| Tradename: | TRIENTINE HYDROCHLORIDE |
| Applicant: | Navinta Llc |
| Ingredient: | trientine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 211251
| Mechanism of Action | Metal Chelating Activity |
Medical Subject Heading (MeSH) Categories for 211251
Suppliers and Packaging for NDA: 211251
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIENTINE HYDROCHLORIDE | trientine hydrochloride | CAPSULE;ORAL | 211251 | ANDA | Navinta LLC | 68475-200 | 68475-200-01 | 1 BOTTLE in 1 CARTON (68475-200-01) / 100 CAPSULE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Jan 16, 2019 | TE: | AB | RLD: | No | ||||
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