Orange Book product · Generic (ANDA)
BENZONATATE
BENZONATATE
At a glance
Jul 30, 2015
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 30, 2015
11 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
BENZONATATE
Strength
100MG
Dosage form
CAPSULE
Route
ORAL
TE code
AA
Application
ANDA 091133
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BENZONATATE
- —TESSALONBrand (NDA)
NDA 011210 · PFIZER
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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 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.
