Orange Book product · Generic (ANDA)
BENZONATATE
BENZONATATE
At a glance
Sep 24, 2014
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 24, 2014
11 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
BENZONATATE
Strength
150MG
Dosage form
CAPSULE
Route
ORAL
TE code
AA
Application
ANDA 040627
Product number
003
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of BENZONATATE
- —TESSALONBrand (NDA)
NDA 011210 · PFIZER
- 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
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.
