Details for New Drug Application (NDA): 017530
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NDA 017530 describes TIGAN, which is a drug marketed by King Pharms Llc and Endo Operations and is included in two NDAs. It is available from three suppliers. Additional details are available on the TIGAN profile page.
The generic ingredient in TIGAN 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 TIGAN 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 017530
| Tradename: | TIGAN |
| Applicant: | Endo Operations |
| Ingredient: | trimethobenzamide hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 017530
| Physiological Effect | Emesis Suppression |
Suppliers and Packaging for NDA: 017530
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIGAN | trimethobenzamide hydrochloride | INJECTABLE;INJECTION | 017530 | NDA | Henry Schein, Inc | 0404-9964 | 0404-9964-02 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9964-02) / 2 mL in 1 VIAL, SINGLE-DOSE |
| TIGAN | trimethobenzamide hydrochloride | INJECTABLE;INJECTION | 017530 | NDA | Endo USA, Inc. | 42023-119 | 42023-119-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (42023-119-25) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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