Orange Book product · Brand (NDA)
TIGAN
TRIMETHOBENZAMIDE HYDROCHLORIDE
At a glance
Dec 13, 2001
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 13, 2001
24 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
TRIMETHOBENZAMIDE HYDROCHLORIDE
Strength
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 017531
Product number
006
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- —TIGANBrand (NDA)
NDA 017530 · PH HEALTH
- 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.
