Details for New Drug Application (NDA): 211251
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The generic ingredient in TRIENTINE HYDROCHLORIDE is trientine hydrochloride. There are ten drug master file entries for this compound. Fourteen 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 |
Formulation / Manufacturing: | see details |
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 | Lannett Company Inc. | 0527-4068 | 0527-4068-37 | 1 BOTTLE in 1 CARTON (0527-4068-37) / 100 CAPSULE in 1 BOTTLE |
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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