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 Par Sterile Products and is included in two NDAs. It is available from four 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. Ten 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. Ten suppliers are listed for this compound. Additional details are available on the trimethobenzamide hydrochloride profile page.
Summary for 017530
| Tradename: | TIGAN |
| Applicant: | Par Sterile Products |
| Ingredient: | trimethobenzamide hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
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 | Par Pharmaceutical, 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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