Orange Book product · Brand (NDA)
TIGAN
TRIMETHOBENZAMIDE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
TRIMETHOBENZAMIDE HYDROCHLORIDE
Strength
100MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 017530
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2001TIGANBrand (NDA)
NDA 017531 · KING PHARMS LLC
- 2025TRIMETHOBENZAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 219606 · BPI LABS
- 2023TRIMETHOBENZAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 205950 · HERITAGE PHARMA AVET
- 2011TRIMETHOBENZAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 091330 · AM REGENT
- 2011TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREEGeneric (ANDA)
ANDA 091329 · AM REGENT
- 2003TRIMETHOBENZAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 076570 · SUN PHARM INDUSTRIES
- 2003TRIMETHOBENZAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 076546 · LUPIN
- 1987TRIMETHOBENZAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 088804 · HOSPIRA
- 1986TRIMETHOBENZAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 088960 · SMITH AND NEPHEW
- 1986TRIMETHOBENZAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 089043 · SMITH AND NEPHEW
- 1986TRIMETHOBENZAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 089094 · SOLOPAK
- 1982TRIMETHOBENZAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 087939 · WATSON LABS
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.

