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FDA Orange Book · active-ingredient family

Trimethobenzamide hydrochloride

Trimethobenzamide hydrochloride is approved as 2 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TIGAN · NDA 017531

2

Brand (NDA)

12

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, injectable

ProductApplicantApplicationTEApproved
TIGANRLDKING PHARMS LLCNDA 017531—Dec 13, 2001
TIGANRLDPH HEALTHNDA 017530APApproved Prior to Jan 1, 1982

Generic (ANDA) products (12)

ProductApplicantApplicationTEApproved
TRIMETHOBENZAMIDE HYDROCHLORIDEBPI LABSANDA 219606APOct 16, 2025
TRIMETHOBENZAMIDE HYDROCHLORIDEHERITAGE PHARMA AVETANDA 205950ABNov 21, 2023
TRIMETHOBENZAMIDE HYDROCHLORIDEAM REGENTANDA 091330—Mar 08, 2011
TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREEAM REGENTANDA 091329—Mar 08, 2011
TRIMETHOBENZAMIDE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 076570—Aug 28, 2003
TRIMETHOBENZAMIDE HYDROCHLORIDELUPINANDA 076546ABAug 20, 2003
TRIMETHOBENZAMIDE HYDROCHLORIDEHOSPIRAANDA 088804—Apr 03, 1987
TRIMETHOBENZAMIDE HYDROCHLORIDESMITH AND NEPHEWANDA 088960—Apr 04, 1986
TRIMETHOBENZAMIDE HYDROCHLORIDESMITH AND NEPHEWANDA 089043—Apr 04, 1986
TRIMETHOBENZAMIDE HYDROCHLORIDESOLOPAKANDA 089094—Apr 04, 1986
TRIMETHOBENZAMIDE HYDROCHLORIDEWATSON LABSANDA 087939—Dec 28, 1982
TRIMETHOBENZAMIDE HYDROCHLORIDEWATSON LABSANDA 086577—Oct 19, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Trimethobenzamide hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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