Orange Book product · Brand (NDA)
TESSALON
BENZONATATE
At a glance
Jun 25, 1999
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 25, 1999
27 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
BENZONATATE
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 011210
Product number
003
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.
- 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.
