Details for New Drug Application (NDA): 212238
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NDA 212238 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 212238
| Tradename: | TRIENTINE HYDROCHLORIDE |
| Applicant: | Rising |
| Ingredient: | trientine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 212238
| Mechanism of Action | Copper Chelating Activity Metal Chelating Activity |
Medical Subject Heading (MeSH) Categories for 212238
Suppliers and Packaging for NDA: 212238
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIENTINE HYDROCHLORIDE | trientine hydrochloride | CAPSULE;ORAL | 212238 | ANDA | Rising Pharma Holdings, Inc. | 16571-810 | 16571-810-01 | 100 CAPSULE in 1 BOTTLE (16571-810-01) |
| TRIENTINE HYDROCHLORIDE | trientine hydrochloride | CAPSULE;ORAL | 212238 | ANDA | Rising Pharma Holdings, Inc. | 16571-812 | 16571-812-05 | 50 CAPSULE in 1 BOTTLE (16571-812-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Feb 20, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
| Approval Date: | Sep 22, 2023 | TE: | RLD: | No | |||||
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