Details for New Drug Application (NDA): 205950
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NDA 205950 describes TRIMETHOBENZAMIDE HYDROCHLORIDE, which is a drug marketed by Heritage Pharma Avet, Lupin, Sun Pharm Industries, Am Regent, Bpi Labs, Hospira, Smith And Nephew, Solopak, and Watson Labs, and is included in twelve NDAs. It is available from five suppliers. Additional details are available on the TRIMETHOBENZAMIDE HYDROCHLORIDE profile page.
The generic ingredient in TRIMETHOBENZAMIDE HYDROCHLORIDE is trimethobenzamide hydrochloride. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the trimethobenzamide hydrochloride profile page.
The generic ingredient in TRIMETHOBENZAMIDE HYDROCHLORIDE is trimethobenzamide hydrochloride. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the trimethobenzamide hydrochloride profile page.
Summary for 205950
| Tradename: | TRIMETHOBENZAMIDE HYDROCHLORIDE |
| Applicant: | Heritage Pharma Avet |
| Ingredient: | trimethobenzamide hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 205950
| Physiological Effect | Emesis Suppression |
Suppliers and Packaging for NDA: 205950
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIMETHOBENZAMIDE HYDROCHLORIDE | trimethobenzamide hydrochloride | CAPSULE;ORAL | 205950 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-180 | 23155-180-01 | 100 CAPSULE in 1 BOTTLE (23155-180-01) |
| TRIMETHOBENZAMIDE HYDROCHLORIDE | trimethobenzamide hydrochloride | CAPSULE;ORAL | 205950 | ANDA | Chartwell RX, LLC | 62135-773 | 62135-773-30 | 30 CAPSULE in 1 PACKAGE (62135-773-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Nov 21, 2023 | TE: | AB | RLD: | No | ||||
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