Orange Book product · Brand (NDA)
TESSALON
BENZONATATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
BENZONATATE
Strength
100MG
Dosage form
CAPSULE
Route
ORAL
TE code
AA
Application
NDA 011210
Product number
001
Marketing status
RX
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.
- 2026BENZONATATEGeneric (ANDA)
ANDA 220298 · MARKSANS PHARMA
- 2019BENZONATATEGeneric (ANDA)
ANDA 211518 · ASCENT PHARMS INC
- 2018BENZONATATEGeneric (ANDA)
ANDA 206948 · PURACAP PHARM LLC
- 2018BENZONATATEGeneric (ANDA)
ANDA 210562 · CHARTWELL RX
- 2017BENZONATATEGeneric (ANDA)
ANDA 202765 · CSPC-NBP PHARM
- 2015BENZONATATEGeneric (ANDA)
ANDA 091133 · ONESOURCE SPECIALTY
- 2015BENZONATATEGeneric (ANDA)
ANDA 091310 · ACELLA
- 2009BENZONATATEGeneric (ANDA)
ANDA 040851 · MIKART
- 2008BENZONATATEGeneric (ANDA)
ANDA 040587 · SUN PHARM INDS INC
- 2007BENZONATATEGeneric (ANDA)
ANDA 040795 · NESHER PHARMS
- 2007BENZONATATEGeneric (ANDA)
ANDA 040682 · HERITAGE PHARMS LABS
- 2007BENZONATATEGeneric (ANDA)
ANDA 040597 · ZYDUS PHARMS USA
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.
