Details for New Drug Application (NDA): 076546
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NDA 076546 describes TRIMETHOBENZAMIDE HYDROCHLORIDE, which is a drug marketed by Avet Lifesciences, Lupin, Sun Pharm Industries, Am Regent, Hospira, Smith And Nephew, Solopak, and Watson Labs, and is included in eleven NDAs. It is available from six suppliers. Additional details are available on the TRIMETHOBENZAMIDE HYDROCHLORIDE profile page.
The generic ingredient in TRIMETHOBENZAMIDE HYDROCHLORIDE is trimethobenzamide hydrochloride. There are six drug master file entries for this compound. Nine 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 are six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the trimethobenzamide hydrochloride profile page.
Summary for 076546
| Tradename: | TRIMETHOBENZAMIDE HYDROCHLORIDE |
| Applicant: | Lupin |
| Ingredient: | trimethobenzamide hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 076546
| Physiological Effect | Emesis Suppression |
Suppliers and Packaging for NDA: 076546
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIMETHOBENZAMIDE HYDROCHLORIDE | trimethobenzamide hydrochloride | CAPSULE;ORAL | 076546 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-660 | 43386-660-03 | 30 CAPSULE in 1 BOTTLE (43386-660-03) |
| TRIMETHOBENZAMIDE HYDROCHLORIDE | trimethobenzamide hydrochloride | CAPSULE;ORAL | 076546 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-660 | 43386-660-24 | 100 CAPSULE in 1 BOTTLE (43386-660-24) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Aug 20, 2003 | TE: | AB | RLD: | No | ||||
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